WorldWideScience

Sample records for drug regulatory authorities

  1. Regulation of stability studies to enhance the efficiency of drug registrations to regulatory authorities

    Directory of Open Access Journals (Sweden)

    Mohammad Sajjad Khan

    2015-01-01

    Full Text Available Stability testing is an important tool to assess the quality of drug substances and products which may vary with time under influence of variety of factors such as temperature, humidity, and light. Stability studies of drugs are designed according to the climatic zones to establish a retest period for active drug substance or a shelf life for the finished product as well as to recommend the storage conditions. The strict regulatory requirements on designing, performing evaluating stability study to claim the expiry date, and shelf life of drug products are based on a series of regulatory requirements and advisory guidelines that have been developed by regulatory authorities of US, Europe, and Japan which; were harmonized through the development of the International Conference on Harmonization (ICH procedures. To assess the stability of drug substances and products, the design and conduct of stability studies, defining relevant thresholds for impurities testing is required with a current good manufacturing practice-based risk management approach to achieve a robust stability of pharmaceutical dosage forms. There are relevant requirements that cover new drug substances and products as well as new dosage forms containing existing active ingredients and vice versa.

  2. International vision and strategy for drug regulatory authority: the PMDA's international vision.

    Science.gov (United States)

    Tominaga, Toshiyoshi; Ando, Yuki; Kondo, Tatsuya

    2012-09-01

    The past several years saw various countries' drug regulatory authorities (DRAs) internationalizing their activities in response to the rapid globalization of pharmaceutical affairs. This is the second surge of internationalization, coming after the first in the 1990s, when the International Conference on Harmonisation (ICH) and the Global Harmonization Task Force were founded. For maximum effect, a DRA needs to carefully strategize its international activities. The significance of international master plans is discussed in relation to the recently published International Vision of Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

  3. The value and benefits of the International Conference on Harmonisation to drug regulatory authorities: advancing harmonization for better public health.

    Science.gov (United States)

    Molzon, J A; Giaquinto, A; Lindstrom, L; Tominaga, T; Ward, M; Doerr, P; Hunt, L; Rago, L

    2011-04-01

    The International Conference on Harmonisation (ICH) is an unparalleled undertaking, which has brought together drug regulatory authorities and pharmaceutical trade associations from Europe, Japan, and the United States, to discuss the scientific and technical aspects of medical product registration. Launched in 1990, the value and benefits of ICH to regulators are being realized. ICH has harmonized submission requirements and created a harmonized submission format that is relieving both companies and regulatory authorities of the burdens of assembling and reviewing separate submissions for each region. As more countries embrace ICH guidelines, we anticipate additional benefits, including the promotion of good review practices and, ultimately, a common regulatory language that will facilitate further interactions among global drug regulatory authorities.

  4. Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA.

    Science.gov (United States)

    Eriksson, Robert; Aagaard, Lise; Jensen, Lars Juhl; Borisova, Liza; Hørlück, Dorte; Brunak, Søren; Hansen, Ebba Holme

    2014-06-01

    Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source of information on safe and effective use of drugs. The objectives of this study were to qualitatively and quantitatively compare PIs for selected drugs marketed in both Denmark and the USA with respect to consistency and discrepancy of listed adverse drug reaction (ADR) information. We compared individual ADRs listed in PIs from Denmark and the USA with respect to type and frequency. Consistency was defined as match of ADRs and of ADR frequency or match could not be ruled out. Discrepancies were defined as ADRs listed only in one country or listed with different frequencies. We analyzed PIs for 40 separate drugs from ten therapeutic groups and assigned the 4003 identified ADRs to System Organ Classes (Medical Dictionary for Regulatory Activities [MedDRA] terminology). Less than half of listed ADRs (n = 1874; 47%) showed consistency. Discrepancies (n = 2129; 53%) were split into ADRs listed only in the USA (n = 1558; 39%), ADRs listed only in Denmark (n = 325; 8%) and ADRs listed with different frequencies (n = 246; 6%). The majority of listed ADRs were of the type "gastrointestinal disorders" and "nervous system disorders". Our results show great differences in PIs for drugs approved in both Denmark and the USA illuminating concerns about the credibility of the publicly available PIs. The results also represent an argument for further harmonization across borders to improve consistency between authority-supplied information.

  5. Prohibition and regulatory authority: a documental research about drugs categorizing administrative process

    Directory of Open Access Journals (Sweden)

    Milena Karla Soares

    2016-09-01

    Full Text Available This work aims to map the decision making process and identify actors and foundation of regulatory normative acts within public policy about drugs, consubstantiated with the edition and updates of Portaria SVS/MS nº 344/1998, which defines rules to substances under special control and forbidden substances in Brazil, and complement the meaning of Law 11.343/2006. A documentary research was made to elucidate the following issues: compliance of the acts of National Agency for Sanitary Vigilance - ANVISA to the actualizations of the lists of the international conventions about the theme; actors who have initiative of the inclusion process of substances; steps of the process; use of social participation, decisional transparency and accountability mechanisms; consulted sources to subsidize the decision and main reasons related in the technical reports. The results shows that there’s not total compliance to the international parameters with the inclusion of substances in the Brazilian controlling lists and that the prohibition is more related to public security reasons than health damages, probably due to asymmetric influence of interest groups in the administrative process.

  6. Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA

    DEFF Research Database (Denmark)

    Eriksson, Robert; Aagaard, Lise; Jensen, Lars Juhl

    2014-01-01

    Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source of information on safe and effective use of drugs. The objectives of this study were to qualitatively and quantitatively compare PIs for selected drugs marketed in both Denmark and the USA with respect...... = 1874; 47%) showed consistency. Discrepancies (n = 2129; 53%) were split into ADRs listed only in the USA (n = 1558; 39%), ADRs listed only in Denmark (n = 325; 8%) and ADRs listed with different frequencies (n = 246; 6%). The majority of listed ADRs were of the type “gastrointestinal disorders......” and “nervous system disorders”. Our results show great differences in PIs for drugs approved in both Denmark and the USA illuminating concerns about the credibility of the publicly available PIs. The results also represent an argument for further harmonization across borders to improve consistency between...

  7. 21 CFR 26.74 - Preservation of regulatory authority.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Preservation of regulatory authority. 26.74 Section 26.74 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... COMMUNITY âFrameworkâ Provisions § 26.74 Preservation of regulatory authority. (a) Nothing in this...

  8. Exemption from registration for persons authorized under U.S. Nuclear Regulatory Commission or agreement state medical use licenses or permits and administering the drug product DaTscan(TM). Interim final rule with request for comment.

    Science.gov (United States)

    2014-11-25

    The Drug Enforcement Administration (DEA) is amending its regulations to waive the requirement of registration for persons who are authorized under United States Nuclear Regulatory Commission or Agreement State medical use licenses or permits and administer the drug product DaTscan(TM).

  9. 75 FR 54210 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Science.gov (United States)

    2010-09-03

    ...-2010-032] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of... Transactions August 30, 2010. On June 17, 2010, the Financial Industry Regulatory Authority, Inc....

  10. 75 FR 30453 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-06-01

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving..., Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of Securities Dealers... National Association of Securities Dealers, Inc., the Financial Industry Regulatory Authority, Inc., or...

  11. 75 FR 40000 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-07-13

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change Relating to the Restated Certificate of Incorporation of Financial Industry Regulatory Authority, Inc. July 2, 2010. On May 21, 2010, Financial Industry Regulatory Authority, Inc....

  12. Independent regulatory authorities in European electricity market

    DEFF Research Database (Denmark)

    Olsen, Ole Jess; Larsen, Anders; Sørensen, Eva Moll

    2006-01-01

    Liberalisation of the electricity market has taken place in most European countries within the last decade. It is considered a precondition of successful liberalisation to establish so-called independent regulatory authorities. In this article, we compare the status and practice of them in 16...

  13. 75 FR 70757 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-11-18

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a... 12, 2010. I. Introduction On August 6, 2010, the Financial Industry Regulatory Authority, Inc... Kimmel, Executive Director, Financial Information Forum, to Elizabeth M. Murphy, Secretary,...

  14. 77 FR 47470 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Science.gov (United States)

    2012-08-08

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Withdrawal... FINRA Rulebook August 2, 2012. On April 22, 2009, the Financial Industry Regulatory Authority,...

  15. 77 FR 55517 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2012-09-10

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a.... Introduction On May 24, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the... General Counsel, Securities Industry and Financial Markets Association, dated June 26, 2012...

  16. 75 FR 62439 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-10-08

    ...-2010-043] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving..., 2010. I. Introduction On August 6, 2010, the Financial Industry Regulatory Authority, Inc. (``FINRA..., 2010 (``Wiesenberg Letter''); Letter from Manisha Kimmel, Executive Director, Financial...

  17. 77 FR 12340 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2012-02-29

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting... Accounting Support Fee February 23, 2012. I. Introduction On December 20, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission...

  18. 76 FR 20757 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2011-04-13

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting... February 4, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the...

  19. 75 FR 61793 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-10-06

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving... Encrypted September 29, 2010. I. Introduction On June 2, 2010, the Financial Industry Regulatory Authority... Taunt, Chief Executive Officer, Regal Financial Group, to Elizabeth M. Murphy, Secretary,...

  20. 75 FR 58004 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-09-23

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... is hereby given that on September 7, 2010, Financial Industry Regulatory Authority, Inc. (``FINRA... Securities Exchange, LLC, Financial Industry Regulatory Authority, Inc., The New York Stock Exchange,...

  1. 75 FR 9459 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-03-02

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... hereby given that Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association... National Association of Securities Dealers, Inc., the Financial Industry Regulatory Authority, Inc., or...

  2. Orphan drugs: the regulatory environment.

    Science.gov (United States)

    Franco, Pedro

    2013-02-01

    The definition of a rare disease is not universal and depends on the legislation and policies adopted by each region or country. The main objective of this article is to describe and discuss the legal framework and the regulatory environment of orphan drugs worldwide. Some reflections and discussions on the need for specific orphan drug legislation or policies are described at length. Furthermore, some aspects of the history of each region in respect of the orphan drug legislation evolution are outlined. This article describes and compares the orphan drug legislation or policies of the following countries or regions: United Sates of America (US), European Union (EU), Japan, Australia, Singapore, Taiwan and Canada. The incentives described in the orphan drug legislations or policies, the criteria for designation of orphan status and the authorisation process of an orphan drug are also described and compared. The legislations and policies are to some extent similar but not the same. It is important to understand the main differences among all available legislative systems to improve the international collaboration in the field of orphan drugs and rare diseases.

  3. 77 FR 1524 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2012-01-10

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving..., 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and... effective date of the proposed rule change in a Regulatory Notice to be published no later than 60...

  4. 78 FR 10655 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2013-02-14

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...) February 8, 2013. I. Introduction On December 20, 2012, Financial Industry Regulatory Authority, Inc... Equity Securities.\\5\\ FINRA may impose a ``Foreign Regulatory Halt'' when a foreign securities...

  5. 77 FR 33527 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-06-06

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... hereby given that on May 23, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with.... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of...

  6. 77 FR 12092 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-02-28

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...\\ notice is hereby given that February 9, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA... interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory...

  7. 75 FR 28841 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-05-24

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... thereunder,\\2\\ notice is hereby given that on May 18, 2010, Financial Industry Regulatory Authority, Inc.... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of...

  8. 76 FR 2739 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-01-14

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... is hereby given that on January 5, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA...-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change FINRA is...

  9. 76 FR 70195 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-11-10

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...,\\2\\ notice is hereby given that on October 28, 2011, Financial Industry Regulatory Authority, Inc.... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of...

  10. 78 FR 42581 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2013-07-16

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... thereunder,\\2\\ notice is hereby given that on June 27, 2013, Financial Industry Regulatory Authority, Inc.... 78s(b)(3)(A)(i). \\4\\ 17 CFR 240.19b-4(f)(1). I. Self-Regulatory Organization's Statement of the...

  11. 77 FR 12098 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-02-28

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... February 9, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and...). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance of...

  12. 76 FR 72463 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-11-23

    ...-FINRA-2011-044] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of... is hereby given that on November 8, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA...\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the...

  13. 76 FR 9840 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-02-22

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... that on February 4, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the.... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of...

  14. 78 FR 78451 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-12-26

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... thereunder,\\2\\ notice is hereby given that on December 9, 2013, Financial Industry Regulatory Authority, Inc.... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of...

  15. 78 FR 25331 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Science.gov (United States)

    2013-04-30

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Withdrawal.... On January 7, 2013, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the... Regulatory Policy, Wells Fargo Advisors, LLC, dated Feb. 15, 2013; Letter from Tamara K. Salmon,...

  16. 76 FR 67787 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-11-02

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... thereunder,\\2\\ notice is hereby given that on October 13, 2011, Financial Industry Regulatory Authority, Inc.... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of...

  17. 78 FR 76341 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-12-17

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... thereunder,\\2\\ notice is hereby given that, on December 2, 2013, Financial Industry Regulatory Authority, Inc... considers the subscriber's financial condition and its regulatory history. FINRA believes that the...

  18. 75 FR 2899 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-01-19

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving... January 12, 2010. On November 24, 2009, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k...- regulatory organizations.\\6\\ \\6\\ See, e.g., Nasdaq Rule 4761 and NYSE-Arca Rule 7.39. It is therefore...

  19. 75 FR 7532 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-02-19

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and...,\\2\\ notice is hereby given that on February 4, 2010, Financial Industry Regulatory Authority, Inc... in Regulatory Notice 09-71 that the new financial responsibility rules will be implemented...

  20. 77 FR 58880 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-09-24

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and...,\\2\\ notice is hereby given that on September 17, 2012, Financial Industry Regulatory Authority, Inc...\\ 15 U.S.C. 78s(b)(3)(A). \\4\\ 17 CFR 240.19b-4(f)(6). I. Self-Regulatory Organization's Statement...

  1. 76 FR 78706 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2011-12-19

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a... On October 20, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the... advised that it would announce the implementation date of the proposed rule change in a Regulatory...

  2. 77 FR 33537 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-06-06

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... is hereby given that on May 24, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed.... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of...

  3. 78 FR 75954 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-12-13

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... thereunder,\\2\\ notice is hereby given that on November 25, 2013, Financial Industry Regulatory Authority, Inc.... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of...

  4. 75 FR 69503 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-11-12

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...\\ notice is hereby given that on October 29, 2010, Financial Industry Regulatory Authority, Inc. (``FINRA.... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of...

  5. 75 FR 15470 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-03-29

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... thereunder,\\2\\ notice is hereby given that, on March 9, 2010, Financial Industry Regulatory Authority, Inc...-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change FINRA is...

  6. 77 FR 5611 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2012-02-03

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a..., 2012. I. Introduction On October 13, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA... change in a Regulatory Notice to be published no later than 90 days following Commission approval,...

  7. 76 FR 66344 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2011-10-26

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving.... Introduction On August 31, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National... Regulatory Notice to be published no later than 90 days following this Commission approval. The...

  8. 75 FR 62901 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-10-13

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... thereunder,\\2\\ notice is hereby given that on September 27, 2010, the Financial Industry Regulatory Authority....19b-4(f)(6). I. Self-Regulatory Organization's Statement of the Terms of Substance of the...

  9. 76 FR 65758 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-10-24

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... thereunder,\\2\\ notice is hereby given that on October 5, 2011, Financial Industry Regulatory Authority, Inc.... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of...

  10. 78 FR 54359 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2013-09-03

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on August 20, 2103, Financial Industry Regulatory.... \\3\\ 15 U.S.C. 78s(b)(3)(A)(i). \\4\\ 17 CFR 240.19b-4(f)(1). ] I. Self-Regulatory...

  11. 76 FR 20065 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-04-11

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on March 30, 2011, Financial Industry Regulatory... interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory...

  12. 75 FR 49542 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-08-13

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... 19b-4 thereunder,\\2\\ notice is hereby given that on July 27, 2010, Financial Industry Regulatory... from interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory...

  13. 78 FR 24261 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2013-04-24

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on April 15, 2013, Financial Industry Regulatory...\\ 17 CFR 240.19b-4(f)(6). I. Self-Regulatory Organization's Statement of the Terms of Substance of...

  14. 75 FR 39069 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-07-07

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on June 30, 2010, Financial Industry Regulatory.... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of...

  15. 75 FR 53998 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-09-02

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on August 16, 2010, Financial Industry Regulatory.... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of...

  16. 76 FR 50515 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-08-15

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on August 5, 2011, Financial Industry Regulatory...-4(f)(6). I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed...

  17. 75 FR 17460 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-04-06

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and...'') \\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on March 26, 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``SEC''...

  18. 78 FR 59995 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-09-30

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on September 16, 2013, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``Commission'')...

  19. 77 FR 5610 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-02-03

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and...\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on January 24, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``Commission'')...

  20. 78 FR 46652 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-08-01

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... thereunder,\\3\\ notice is hereby given that, on July 18, 2013, Financial Industry Regulatory Authority, Inc... as described in Items I, II and III below, which Items have been prepared by the...

  1. 75 FR 27606 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-05-17

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... (``Act'') \\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on April 27, 2010, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of Securities Dealers,...

  2. 77 FR 68181 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-11-15

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on November 2, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``SEC''...

  3. 75 FR 8771 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-02-25

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change To Adopt FINRA Rule 2261 (Disclosure of Financial Condition) in the Consolidated FINRA Rulebook February 18, 2010. On November 18, 2009, the Financial Industry Regulatory Authority,...

  4. 76 FR 65307 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-10-20

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...''),\\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on October 6, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission...

  5. 76 FR 11830 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-03-03

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on February ] 22, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``SEC''...

  6. 77 FR 4599 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-01-30

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on January 10, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``SEC''...

  7. 77 FR 7218 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-02-10

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on January 30, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``SEC''...

  8. 75 FR 36756 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-06-28

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on June 17, 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``SEC''...

  9. 75 FR 59300 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-09-27

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on September 17, 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``Commission'')...

  10. 75 FR 39610 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-07-09

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending Financial Industry Regulatory Authority, Inc...'') \\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on June 24, 2010, Financial...

  11. 76 FR 29808 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2011-05-23

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting... Distributions) May 18, 2011. I. Introduction On April 26, 2011, the Financial Industry Regulatory Authority, Inc... 29, 2011. II. Description of the Proposed Rule Change On November 29, 2010, FINRA issued...

  12. 76 FR 11542 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2011-03-02

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving... 24, 2011. I. Introduction On November 10, 2010, the Financial Industry Regulatory Authority, Inc... fidelity bond will be a great financial burden for small firms.\\16\\ The third commenter agrees with...

  13. 76 FR 68240 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-11-03

    ...-2011-062] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on October 20, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``SEC''...

  14. 77 FR 1119 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-01-09

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...'') \\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on December 19, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission...

  15. 76 FR 77034 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-12-09

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and...''),\\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on December 2, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange...

  16. 76 FR 61773 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-10-05

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... Expansion of the Order Audit Trail System to All NMS Stocks September 29, 2011. Pursuant to Section 19(b)(1... given that on September 27, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed...

  17. 76 FR 81551 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2011-12-28

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change Relating to Amendments to the Order Audit Trail System Rules December 21, 2011. I. Introduction On October 28, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with...

  18. 76 FR 25399 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-05-04

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... of the Order Audit Trail System to All NMS Stocks April 29, 2011. Pursuant to Section 19(b)(1) of the... April 26, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities...

  19. 75 FR 69725 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-11-15

    ...-2010-058] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of... the FINRA Trade Reporting and Order Audit Trail System Rules Approved in SR-FINRA-2010-043 November 8... thereunder,\\2\\ notice is hereby given that on November 5, 2010, Financial Industry Regulatory Authority,...

  20. 76 FR 71404 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-11-17

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to the Order Audit Trail System Definitions of... November 4, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities...

  1. 76 FR 37384 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-06-27

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Exemptions from the Order Audit Trail System..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange...

  2. 76 FR 74105 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-11-30

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... November 21, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and... significant increase in trading pauses involving rights and warrants since the inclusion of the Phase...

  3. The Dutch drug policy from a regulatory perspective

    NARCIS (Netherlands)

    Spapens, A.C.M.; Müller, T.; Van de Bunt, H.G.

    2015-01-01

    Starting in the 1970s, the Netherlands developed a regulatory regime for narcotic drugs by distinguishing between hashish and marihuana (“soft drugs”) and other drugs (“hard drugs”). The authorities decided to cease prosecuting the possession of consumer quantities of the former type and to allow

  4. The Dutch drug policy from a regulatory perspective

    NARCIS (Netherlands)

    Spapens, A.C.M.; Müller, T.; Van de Bunt, H.G.

    2015-01-01

    Starting in the 1970s, the Netherlands developed a regulatory regime for narcotic drugs by distinguishing between hashish and marihuana (“soft drugs”) and other drugs (“hard drugs”). The authorities decided to cease prosecuting the possession of consumer quantities of the former type and to allow th

  5. The Dutch drug policy from a regulatory perspective

    NARCIS (Netherlands)

    Spapens, A.C.M.; Müller, T.; Van de Bunt, H.G.

    2015-01-01

    Starting in the 1970s, the Netherlands developed a regulatory regime for narcotic drugs by distinguishing between hashish and marihuana (“soft drugs”) and other drugs (“hard drugs”). The authorities decided to cease prosecuting the possession of consumer quantities of the former type and to allow th

  6. 75 FR 30457 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-06-01

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule Change Relating to the Restated Certificate of Incorporation of Financial Industry Regulatory...'') \\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on May 21, 2010, Financial...

  7. 78 FR 37261 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-06-20

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on June 3, 2013, Financial Industry Regulatory... rule change from interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I....

  8. Delegation to Independent Regulatory Authorities in the Media Sector: A Paradigm Shift through the Lens of Regulatory Theory

    NARCIS (Netherlands)

    K. Irion; R. Radu

    2014-01-01

    Today, it seems that independent regulatory authorities have almost become a natural institutional form for regulatory governance. This trend has economic and political roots, and numerous normative arguments for creating independent regulatory authorities have been put forward in the international

  9. DRUG REGULATORY STATUS ASSIGNMENT CRITERIA: A CONTRAST AMONG 2 COUNTRIES

    Directory of Open Access Journals (Sweden)

    Anoop Paruchuri*, Vini Pavithran , M. Pavani , S. Selvamuthukumaran and G. P. Mohanta

    2013-01-01

    Full Text Available After a laborious and extravagant procedure the drug finally enters the market for use. But who determines the new drug status as a prescription only or an OTC? There is a clear cut contrast between the US and India with respect to their assignment guidelines and the future prospect of a new drug. In the US the regulatory status of the approved drug is determined as per the FDA guidelines (FDCA of 1938 in accordance with the Durham-Humphrey act of 1951 which depicts the criteria required for a pharmaceutical product to be marketed as a prescription drug or an OTC product. CDSCO headed by the DCGI is the authority responsible for determining the regulatory status which acts as per the regulations listed in Drugs and Cosmetics Act of 1940 in India. The US regulatory system stipulates the malleability for the inter conversion of the drugs regulatory status known as “Rx to OTC switch” which is deficient in India. Perfect implementation of regulations in India will promote effective use of OTC’s and forestall illicit sale of prescription drugs as OTC’s.

  10. 76 FR 64419 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-10-18

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Revise the Series 7 Examination Program September...

  11. 78 FR 3925 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-01-17

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule Change Relating to Amendments to the Customer and Industry Codes of Arbitration Procedure To... proposing to amend the Customer and Industry Codes of Arbitration Procedure (``Codes'') to revise the...

  12. 75 FR 42795 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-07-22

    ... Disputes (``Customer Code'') and Rule 13602 of the Code of Arbitration Procedure for Industry Disputes (``Industry Code'') (collectively, the ``Codes'') to provide that a non-party witness may be represented by an... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

  13. 77 FR 74712 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2012-12-17

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change To Amend the Customer and Industry Codes of Arbitration Procedure Relating to... and Industry Codes of Arbitration Procedure (collectively, the ``Codes'') (1) to provide that when...

  14. 75 FR 7297 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-02-18

    ... Arbitration Procedure for Industry Disputes (``Industry Code'') (together, the ``Codes'') to clarify the... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change To Amend the Postponement Fee and Hearing Session Fee Rules of the Codes of...

  15. 75 FR 8169 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-02-23

    ... the Code of Arbitration Procedure for Industry Disputes (``Industry Code'') (together, ``Codes'') to... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule Change To Amend the Codes of Arbitration Procedure To Provide for Attorney Representation of...

  16. 75 FR 52380 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-08-25

    ...-2010-044] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule Change Relating to the Expansion of the Order Audit Trail System to All NMS...\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on August 6, 2010, the Financial...

  17. 78 FR 37267 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-06-20

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... 1934 (``Act'') \\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on June 3, 2013, Financial... the mandatory inclusion of a non- public arbitrator in a three-arbitrator case raised a...

  18. 76 FR 9838 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-02-22

    ... Arbitration Procedure for Industry Disputes (``Industry Code'') to provide that FINRA will appoint a chair... procedures leads FINRA to propose amending the Industry Code to provide that FINRA will appoint a chair... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

  19. 75 FR 41262 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-07-15

    ... Arbitration Procedure for Industry Disputes (``Industry Code'') to increase ] the number of arbitrators on.... FINRA also proposed to amend Rule 13403 of the Industry Code to expand the number of arbitrators on... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

  20. 76 FR 20741 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2011-04-13

    ... the Code of Arbitration Procedure for Industry Disputes (``Industry Code'') to provide that FINRA will... procedures led FINRA to propose amending the Industry Code to provide that FINRA will appoint a chair... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

  1. 75 FR 29594 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-05-26

    ... 13404 of the Code of Arbitration Procedure for Industry Disputes (``Industry Code'') to increase the... the Industry Code to expand the number of arbitrators on lists generated through NLSS.\\8\\ For disputes...-2010-022] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

  2. Regulatory and Economic Considerations of Retinal Drugs.

    Science.gov (United States)

    Shah, Ankoor R; Williams, George A

    2016-01-01

    The advent of anti-VEGF therapy for neovascular age-related macular degeneration and macular edema secondary to retinal vein occlusion and diabetes mellitus has prevented blindness in tens of thousands of people. However, the costs of these drugs are without precedent in ophthalmic drug therapeutics. An analysis of the financial implications of retinal drugs and the impact of the Food and Drug Administration on treatment of retinal disease must include not only an evaluation of the direct costs of the drugs and the costs associated with their administration, but also the cost savings which accrue from their clinical benefit. This chapter will discuss the financial and regulatory issues associated with retinal drugs.

  3. [Drug-induced oesophageal ulcers (author's transl)].

    Science.gov (United States)

    Kobler, E; Bühler, H; Nüesch, H J; Deyhle, P

    1978-06-23

    Within a one-year period seven patients were observed who had developed ulcers of the upper and mid oesophagus after treatment with doxycycline hydrochloride (n = 3), emepronium bromide (n = 3) or Pantogar (n = 1). In each instance the drug had apparently been swallowed dry. The typical symptoms were a sudden onset of retrosternal chest pain and odynophagia during bed rest. Once the drug had been discontinued and treatment with antacid combined with topical anaesthetics and/or alginic acid instituted the symptoms disappeared within a few days. The authors stress that drugs should be swallowed only with good amounts of fluid and generally not immediately before bed rest.

  4. Drug development: how academia, industry and authorities interact.

    Science.gov (United States)

    Garattini, Silvio; Perico, Norberto

    2014-10-01

    Unfortunately, abundant examples could be given of pitfalls in the current drug development paradigm-including in the design, conduct and evaluation of phase III clinical trials. This article discusses issues of particular relevance to clinical trials in nephrology, including the inappropriate use of placebo, publication of reports that emphasize potential treatment benefits over adverse reactions, the sometimes dubious impartiality of independent guidelines, and inadequate recruitment of elderly patients. This Perspectives article aims to highlight and summarize the flaws in the current drug development process, while suggesting a way forward that equally satisfies the requirements of academia, patients and the pharmaceutical industry. We suggest improvements to the drug development process and related legislation that intend to balance public needs with commercial aims and ensure effective drug evaluation by regulatory authorities.

  5. From molecule to market access: drug regulatory science as an upcoming discipline.

    Science.gov (United States)

    Gispen-de Wied, Christine C; Leufkens, Hubertus G M

    2013-11-05

    Regulatory science as a discipline has evolved over the past years with the object to boost and promote scientific rationale behind benefit/risk and decision making by regulatory authorities. The European Medicines Agency, EMA, the Food and Drug Administration, FDA, and the Japanese Pharmaceutical and Medical Devices Agency, PMDA, highlighted in their distinct ways the importance of regulatory science as a basis of good quality assessment in their strategic plans. The Medicines Evaluation Board, MEB, states: 'regulatory science is the science of developing and validating new standards and tools to evaluate and assess the benefit/risk of medicinal products, facilitating sound and transparent regulatory decision making'. Through analysis of regulatory frameworks itself and their effectiveness, however, regulatory science can also advance knowledge of these systems in general. The comprehensive guidance that is issued to complete an application dossier for regulatory product approval has seldomly been scrutinized for its efficiency. Since it is the task of regulatory authorities to protect and promote public health, it is understood that they take a cautious approach in regulating drugs prior to market access. In general, the authorities are among the first to be blamed if dangerous or useless drugs were allowed to the market. Yet, building a regulatory framework that is not challenged continuously in terms of deliverables for public health and cost-effectiveness, might be counterproductive in the end. Regulatory science and research can help understand how and why regulatory decisions are made, and where renewed discussions may be warranted. The MEB supports regulatory science as an R&D activity to fuel primary regulatory processes on product evaluation and vigilance, but also invests in a 'looking into the mirror' approach. Along the line of the drug life-cycle, publicly available data are reviewed and their regulatory impact highlighted. If made explicit

  6. 76 FR 21932 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2011-04-19

    ... the Financial Industry Regulatory Authority, Inc. (``FINRA'') to amend Rule 13806 of the Code of Arbitration Procedure for Industry Disputes (``Industry Code''). Commission staff discovered that a statement...,\\2\\ a proposed rule change to amend Rule 13806 of the Code of Arbitration Procedure for Industry...

  7. Practice of Regulatory Science (Drug Development).

    Science.gov (United States)

    Kawanishi, Toru

    2017-01-01

     The practice of regulatory science (RS) for drug development is described. In the course material for education in pharmaceutical sciences drafted by the RS Division of the Pharmaceutical Society of Japan, RS for pharmaceuticals is defined as the science of predicting, assessing, and judging the quality, efficacy, and safety of pharmaceutical products throughout their lifespan. RS is also described as an integrated science based on basic and applied biomedical sciences, including analytical chemistry, biochemistry, pharmacology, toxicology, genetics, biostatistics, epidemiology, and clinical trial methodology, and social sciences such as decision science, risk assessment, and communication science. The involvement of RS in drug development generally starts after the optimization of lead compounds. RS plays important roles governing pharmaceuticals during their entire life cycle management phase as well as the drug development phase.

  8. 42 CFR 447.506 - Authorized generic drugs.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Authorized generic drugs. 447.506 Section 447.506... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS PAYMENTS FOR SERVICES Payment for Drugs § 447.506 Authorized generic drugs. (a) Authorized generic drug defined. For the purposes of this subpart, an authorized generic...

  9. The Document of the Americas: Good Clinical Practices for Regulatory Authorities

    Directory of Open Access Journals (Sweden)

    Ricardo Palacios

    2009-12-01

    Full Text Available In 1996, when the Guidelines for Good Clinical Practices of the International Conference on Harmonization (ICH were adopted, they sought to facilitate the actions of regulatory authorities over the different players of clinical research. These guidelines were created and incorporated to the legislation of the three regions of the world (United States, European Union, and Japan where most of the drugs, vaccines, biologicals, diagnostic tests, and medical devices are produced. The regulatory authorities from those three regions are characterized for their extensive technical capacity to execute their mission of promoting technological advances and protecting communities. However, undertaking this task has been difficult, partially because the ICH Good Clinical Practices defined responsibilities for Ethical Committees, Sponsors, and Investigators; but the regulatory authorities did not precise their own responsibilities or indicate how they would accomplish their duties in that document and, therefore, did not reach the harmonization of their practices in those subjects. Certainly, this point is one of the major advances offered by the Document of the Americas on Good Clinical Practices: helping the regulatory authorities of the continent to establish a common platform on how to perform their duties regarding clinical research. The possibilities that this common regulatory methodology offers to the authorities from our countries, with greater limitations in budget and in human resources than their ICH counterparts, are promising: it might allow unified staff training, conduction of joint inspections and, even, thinking of a mutual recognition for the actions of the authorities in each country, as occurred in Europe more than three decades ago. However, the promises have not been delivered in the desired extension: despite the March 2005 meeting held in the Dominican Republic, where the Document of the Americas was published, was held in March, 2005

  10. Post-marketing drug withdrawals: Pharmacovigilance success, regulatory problems.

    Science.gov (United States)

    Aronson, Jeffrey K

    2017-03-30

    Modern pharmacovigilance began in the 1960s, since when the subject has grown markedly, interest having particularly increased since 2010. One index of its success is the increasing speed with which serious adverse drug reactions are discovered after marketing of a medicinal product. However, the speed with which products have subsequently been withdrawn as a result of the discovery of serious adverse reactions has not consistently changed. This highlights problems that regulators and manufacturers face when serious reactions are discovered, with difficulties in deciding which of several consequent actions to take: to add specific warnings (cautions) or contraindications to the product label; to issue a Direct Healthcare Professional Communication; to allow informed patients to decide whether they will take the drug; or, in the most serious cases, to withdraw the product or revoke the licence. Conflicts of interest may inhibit decision-making. Recommendations that arise from these observations are that: health professionals and patients should be more vigorously encouraged to report suspected adverse drug reactions; regulatory authorities and drug manufacturers should take quicker confirmatory action when serious suspected adverse drug reactions are reported, even anecdotally, with formal studies to test for causality conducted sooner rather than later, applying lower than usual thresholds for suspicion; temporary suspensions or restrictions could be considered during such assessments; universal guidelines are needed for determining when a drug should be withdrawn if serious adverse drug reactions are suspected; there should be more rigorous monitoring and verification of deaths and reporting of reasons for drop-outs during clinical trials, with more transparency in reporting adverse events and ready access to premarketing clinical study reports; post-marketing drug monitoring systems and medicines regulation in low-to-middle income economies, especially in Africa

  11. Regulatory bioinformatics for food and drug safety.

    Science.gov (United States)

    Healy, Marion J; Tong, Weida; Ostroff, Stephen; Eichler, Hans-Georg; Patak, Alex; Neuspiel, Margaret; Deluyker, Hubert; Slikker, William

    2016-10-01

    "Regulatory Bioinformatics" strives to develop and implement a standardized and transparent bioinformatic framework to support the implementation of existing and emerging technologies in regulatory decision-making. It has great potential to improve public health through the development and use of clinically important medical products and tools to manage the safety of the food supply. However, the application of regulatory bioinformatics also poses new challenges and requires new knowledge and skill sets. In the latest Global Coalition on Regulatory Science Research (GCRSR) governed conference, Global Summit on Regulatory Science (GSRS2015), regulatory bioinformatics principles were presented with respect to global trends, initiatives and case studies. The discussion revealed that datasets, analytical tools, skills and expertise are rapidly developing, in many cases via large international collaborative consortia. It also revealed that significant research is still required to realize the potential applications of regulatory bioinformatics. While there is significant excitement in the possibilities offered by precision medicine to enhance treatments of serious and/or complex diseases, there is a clear need for further development of mechanisms to securely store, curate and share data, integrate databases, and standardized quality control and data analysis procedures. A greater understanding of the biological significance of the data is also required to fully exploit vast datasets that are becoming available. The application of bioinformatics in the microbiological risk analysis paradigm is delivering clear benefits both for the investigation of food borne pathogens and for decision making on clinically important treatments. It is recognized that regulatory bioinformatics will have many beneficial applications by ensuring high quality data, validated tools and standardized processes, which will help inform the regulatory science community of the requirements

  12. Challenges in orphan drug development and regulatory policy in China

    OpenAIRE

    Cheng, Alice; Xie, Zhi

    2017-01-01

    While regulatory policy is well defined for orphan drug development in the United States and Europe, rare disease policy in China is still evolving. Many Chinese patients currently pay out of pocket for international treatments that are not yet approved in China. The lack of a clear definition and therefore regulatory approval process for rare diseases has, until now, de-incentivized pharmaceutical companies to pursue rare disease drug development in China. In turn, many grassroots movements ...

  13. Towards medicines regulatory authorities' quality performance improvement: value for public health.

    Science.gov (United States)

    Pejović, Gordana; Filipović, Jovan; Tasić, Ljiljana; Marinković, Valentina

    2016-01-01

    The purpose of this article is to explore the possibility of implementing total quality management (TQM) principles in national medicines regulatory authorities in Europe to achieve all public health objectives. Bearing in mind that medicines regulation is a governmental function that serves societal objectives to protect and promote public health, measuring the effective achievement of quality objectives related to public health is of utmost importance. A generic TQM model for meeting public health objectives was developed and was tested on 10 European national medicines regulatory authorities with different regulatory performances. Participating national medicines regulatory authorities recognised all TQM factors of the proposed model in implemented systems with different degrees of understanding. An analysis of responses was performed within the framework of two established criteria-the regulatory authority's category and size. The value of the paper is twofold. First, the new generic TQM model proposes to integrate four public health objectives with six TQM factors. Second, national medicines regulatory authorities were analysed as public organisations and health authorities to develop a proper tool for assessing their regulatory performance. The paper emphasises the importance of designing an adequate approach to performance measurement of quality management systems in medicines regulatory authorities that will support their public service missions.

  14. Tobacco regulatory science: research to inform regulatory action at the Food and Drug Administration's Center for Tobacco Products.

    Science.gov (United States)

    Ashley, David L; Backinger, Cathy L; van Bemmel, Dana M; Neveleff, Deborah J

    2014-08-01

    The U.S. Food and Drug Administration (FDA) promotes the development of regulatory science to ensure that a strong evidence base informs all of its regulatory activities related to the manufacture, marketing, and distribution of tobacco products as well as public education about tobacco product constituents and effects. Toward that end, the FDA's Center for Tobacco Products (CTP) provides funding for research studies with scientific aims that fall within its defined regulatory authority. However, given their traditional biomedical focus on basic and applied research, some researchers may not understand the principles of regulatory science or the types of studies CTP funds. The purpose of this paper is (1) to clarify the definition of regulatory science as a distinct scientific discipline, (2) to explore the role of tobacco regulatory science in order to help researchers understand the parameters and types of research that can be funded by CTP, and (3) to describe the types of research efforts that will inform the FDA's public health framework for tobacco product regulation. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.

  15. 75 FR 8772 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-02-25

    ... FINRA Rulebook February 18, 2010. I. Introduction On December 31, 2009, Financial Industry Regulatory... rules be designed to prevent fraud and manipulative practices and to promote just and equitable...

  16. Regulatory approval pathways for anticancer drugs in Japan, the EU and the US.

    Science.gov (United States)

    Nagai, Sumimasa; Ozawa, Keiya

    2016-07-01

    The Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labour and Welfare in Japan and the US Food and Drug Administration are responsible for reviewing applications and approving drugs, medical devices, and regenerative medicines. In the EU, the European Medicines Agency is responsible for the centralized authorization procedure of medicines including oncologic drugs. In this review, we discuss general pathways for the marketing authorization of oncologic drugs and other drugs in Japan, the EU, and the US. There are still unmet medical needs in oncology, whereas scientific innovation and clinical development in oncology are rapid and active, suggesting a reasonable scope for new regulatory schemes for expedited review. Because regulatory schemes are also evolving rapidly, clinicians and academic researchers may have difficulty following the updated regulations in other regions as well as those in their own countries. However, keeping current with new regulations is important for the conduct of translational research and clinical development of new therapeutic products efficiently. This review is intended to help an international audience better understand the essence of the regulatory frameworks for the marketing authorization of oncologic drugs in Japan, the EU, and the US.

  17. [Role of Academia in Regulatory Science for Global Drug Development].

    Science.gov (United States)

    Tsukamoto, Katsura; Takenaka, Toichi

    2016-01-01

    As diseases know no national boundaries, drug development must be designed at a global level. Drugs are highly regulated to maximize the benefits to public health, which is assessed on a regional basis. The complexity and diversity of stakeholders increase dramatically once multiple international regions are involved. Each stakeholder in drug development depends on customized criteria to make decisions for its own benefit. Thus, a huge gap exists among drug discovery researchers, developers, clinicians, patients, and regulatory bodies. With reasonable scientific evidence gathered and analyzed, mutual agreement can be reached. We believe that this important role of regulatory science and academic involvement will create harmony. By practicing diverse, innovative regulatory scientific research, academia has the potential to become the core of communication among various stakeholder groups. Furthermore, another important responsibility of academia, i.e., knowledge, provides additional aspects to the field of drug development. Those who understand regulatory science can contribute to the efficient achievement of innovative, effective, safe drugs. Thus, research and education are essential roles of academia to allow a better understanding of the balance between benefits and risks. Communication and knowledge will promote the prompt delivery of better medical products to patients in need.

  18. 77 FR 12635 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-03-01

    ... office of FINRA and at the Commission's Public Reference Room. II. Self-Regulatory Organization's... the investment banking or securities business of a FINRA member who are to function as principals or...-sponsored and co-sponsored examinations to cover the development, maintenance, and delivery of these...

  19. 75 FR 56608 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-09-16

    ... uniform, market-wide trading pauses will serve to prevent potentially destabilizing price volatility and... public interest. II. Description of the Proposals On May 6, 2010, the U.S. equity markets experienced a... Emerging Regulatory Issues, ``Preliminary Findings Regarding the Market Events of May 6, 2010,'' dated May...

  20. 76 FR 67236 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-10-31

    ... been approved by a bankruptcy court), while other transactions must be reported to FINRA for regulatory.... Additionally, members must provide FINRA at least three business days advance written notice of their intent to... least three business days advance written notice of their intent to rely on this exception, including...

  1. 76 FR 43360 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-07-20

    ... clearing services using a margin methodology approved by FINRA as announced in a Regulatory Notice (``approved margin methodology''). The Interim Pilot Program shall automatically expire on January 17, 2012... otherwise meet such definition but for being subject to individual negotiation,] include any product that...

  2. 77 FR 38866 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-06-29

    ...-regulatory organizations (``SROs'') to do so by submitting a single form, fingerprint card and a combined... regularly enhanced the CRD system by adding features and functionality (e.g., work queues, standard reports...). Fingerprint Fees FINRA processes fingerprints submitted by members on behalf of their associated persons...

  3. 78 FR 62831 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-10-22

    ..., Secretary, SEC, dated July 25, 2013 (``Brandenburger''); Steve Putnam, Financial Advisor, Raymond James Financial Services, to Elizabeth M. Murphy, Secretary, SEC, dated July 25, 2013 (``Putnam''); Nina.... Murphy, Secretary, SEC, dated July 29, 2013 (``Sweeney''); Robert J. McCarthy, Director of Regulatory...

  4. Drug-device combination products: regulatory landscape and market growth.

    Science.gov (United States)

    Bayarri, L

    2015-08-01

    Combination products are therapeutic and diagnostic products that combine drugs, devices and/or biological products, leading to safer and more effective treatments thanks to careful and precise drug targeting, local administration and individualized therapy. These technologies can especially benefit patients suffering from serious diseases and conditions such as cancer, heart disease, multiple sclerosis and diabetes, among others. On the other hand, drug-device combination products have also introduced a new dynamic in medical product development, regulatory approval and corporate interaction. Due to the increasing integration of drugs and devices observed in the latest generation of combination products, regulatory agencies have developed specific competences and regulations over the last decade. Manufacturers are required to fully understand the specific requirements in each country in order to ensure timely and accurate market access of new combination products, and the development of combination products involves a very specific pattern of interactions between manufacturers and regulatory agencies. The increased sophistication of the products brought to market over the last couple of decades has accentuated the need to develop drugs and devices collaboratively using resources from both industries, fostering the need of business partnering and technology licensing. This review will provide a global overview of the market trends, as well as (in the last section) an analysis of the drug-device combination products approved by the FDA during the latest 5 years. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.

  5. 78 FR 20325 - 2013 Parenteral Drug Association/Food and Drug Administration Joint Regulatory Conference...

    Science.gov (United States)

    2013-04-04

    ... Manufacturing Organizations. Contract Agreements. Drug Safety. Emerging Active Pharmaceutical Ingredients (API... industry as well as explore strategies and approaches for ensuring conformance with regulations to... the development of global regulatory strategies, while industry professionals from some of...

  6. 76 FR 68800 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-11-07

    ...''); letter from Alexander C. Gavis, Fidelity Investments, dated August 24, 2011 (``Fidelity Letter''); letter... delegated authority.\\19\\ \\19\\ 17 CFR 200.30-3(a)(12); 17 CFR 200.30-3(a)(57). Kevin M. O'Neill, Deputy...

  7. Does the FDA have regulatory authority over adult autologous stem cell therapies? 21 CFR 1271 and the emperor's new clothes

    Directory of Open Access Journals (Sweden)

    Freeman Michael

    2012-03-01

    Full Text Available Abstract FDA has recently asserted that many autologous cell therapies once considered the practice of medicine are in fact drugs. These changes began with the creation of new sections of 21 CFR 1271 and a subsequent one word change where the FDA, without public commentary, altered a single word in its regulatory language regarding cell and tissue based therapies that asserted the authority to classify autologous tissue as drugs. The bright line between medical care and drug production can be delineated in many ways, but a simple metric that defines the dichotomy is the consent status of the patient. In healthcare, a patient can either be consented individually for a medical procedure or exposed to an unconsented risk where regulatory assurances are already in place. These new FDA policies apply rules meant to keep drugs safe in a drug factory (unconsented mass production risks to individually consented surgical procedures. We argue that there is little societal benefit to these changes and that they are already stifling medical innovation.

  8. Exploratory and regulatory assessments on photosafety of new drug entities.

    Science.gov (United States)

    Seto, Yoshiki; Hosoi, Kazuhiro; Takagi, Hironori; Nakamura, Kazuichi; Kojima, Hajime; Yamada, Shizuo; Onoue, Satomi

    2012-04-01

    Drug-induced phototoxicity is elicited after exposure of the skin and/or eyes to topically or systemically administered pharmaceutical substances, followed by exposure to sunlight. This undesirable side effect is one of the impediments in drug discovery and development, and substantial efforts have been made to avoid drug-induced phototoxic reactions. To evaluate the phototoxic potential of compounds, effective methodologies have been developed over the past few years, and screening strategies have also been proposed for predicting in vivo phototoxic reactions. European and American regulatory agencies have published guidelines for predicting and avoiding drug-induced phototoxicity in an early phase of drug discovery. The guidelines have indicated the requirements for assessing the photosafety of chemicals on the basis of their photochemical behaviors and have recommended some phototoxic assessment tools for aiding new drug development. A number of phototoxic screening systems have also been proposed on the basis of the pathogenesis of drug-induced phototoxicity, and some of them have already been applied to the phototoxic evaluation of new drug entities in drug discovery and development. The present review aims to summarize the current status of research tools, screening strategy and regulations for evaluating the photosafety of new drug candidates and to introduce our thoughts on the phototoxic risk assessments of compounds.

  9. [Interplay between marketing authorization and early benefit assessment of drugs].

    Science.gov (United States)

    Beinlich, Peggy; Müller-Berghaus, J; Sudhop, T; Vieths, S; Broich, K

    2015-03-01

    The early benefit assessment of newly approved drugs with new active substances or new applications that came into force on 1 January 2011 still presents a challenge to the parties involved. This article highlights the interplay between drug marketing approval and early benefit assessment. The constellation of a European, and even an international, largely harmonized, drug authorization process, with a mostly nationally regulated drug reimbursement situation causes inevitably friction, which could be reduced through joint advice discussions during the planning phase for pivotal studies. In 2013, the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI) provided 439 scientific advice procedures, compared with 98 advice meetings held at the Federal Joint Committee (G-BA), for 12 of which the BfArM or PEI provided written advice. The numbers of advice meetings held at the G-BA are increasing; however, the national competent authorities are involved in only a fraction of these. From the perspective of the national competent authorities, prompt and consistent involvement in the advice procedures regarding early benefit assessment would be useful and desirable.

  10. 76 FR 45631 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-07-29

    ... Procedure for Industry Disputes (``Industry Code'') to broaden arbitrators' authority to make referrals... in harm to investors, FINRA has reviewed the Customer and Industry Codes (together, Codes) and... case. Currently, Rule 12104(b) of the Customer Code and Rule 13104(b) of the Industry Code state, in...

  11. 75 FR 60843 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-10-01

    ... Commission, by the Division of Trading and Markets, pursuant to delegated authority.\\9\\ Florence E. Harmon... reporting facilities and sets forth guidance on the use of the price-override indicator in trade reports... the FINRA Facilities. Additionally, the Notice advises members that the price-override indicator...

  12. Drug lag and key regulatory barriers in the emerging markets.

    Science.gov (United States)

    Wileman, Harriet; Mishra, Arun

    2010-04-01

    There have been numerous investigations targeted at identifying whether a drug lag exists in the mature markets of the US, EU and Japan. This work focuses on the emerging markets because of the potential they hold for the future of the pharmaceutical industry as a consequence of rapid economic and political development.The aims of this work are to ascertain whether a drug lag exists in the emerging markets and how it has changed over time from the 1960s to the 2000s. It will also highlight key regulatory barriers which may contribute to drug lag.The date of the marketing authorisation (MA) approval by the US Food and Drug Administration (FDA) was used as a reference point. A comparison against the company database regarding emerging market specific approval enabled the difference in time and thus the drug lag for that particular market to be calculated.This work concludes that the overall relative drug lag in the emerging markets has decreased over time and that there are seven key regulatory barriers which need to be targeted in order to make further improvements; 'Western Approval', local clinical development (LCD), Certificate of Pharmaceutical Product (CPP), Good Manufacturing Practice (GMP), pricing approval, document authentication and harmonisation.

  13. Enhancement of Regulatory Supervision of the nuclear legacy in northwest Russia: involving the military authorities

    Energy Technology Data Exchange (ETDEWEB)

    Roudak, S.F.; Sneve, M.K.; Bulatov, O.R.; Vasiliev, A.P.; Malinkin, V.M.

    2011-10-15

    This report describes work carried out within the cooperation programme between the Norwegian Radiation Protection Authority and the Directorate of State Supervision for Nuclear and Radiation Safety of the Ministry of Defense of the Russian Federation performed in 2008-2009. It focuses on development of improved regulatory documents and supervision procedures for handling spent nuclear fuel and radioactive waste at facilities that are no longer used by the Russian Federation Navy but that are still under military supervision and control. (Author)

  14. Regulation without Representation? : Independent Regulatory Authorities and Representative Claim-Making in the Netherlands

    NARCIS (Netherlands)

    van Veen, A.

    2014-01-01

    Independent regulatory authorities (IRAs) today have considerable competences. They can regulate and supervise the behaviour of market and societal parties, and set prices for goods and services. They can enforce regulations through fines and ‘naming and shaming’. Thirdly, they have quasi-judicial f

  15. 78 FR 78422 - Order Granting Application by Financial Industry Regulatory Authority, Inc. for Exemption...

    Science.gov (United States)

    2013-12-26

    ... from Robert L.D. Colby, Chief Legal Officer, FINRA, to Elizabeth M. Murphy, Secretary, Commission.... 67256 (June 26, 2012), 77 FR 39277, 39286 (July 2, 2012) (order approving SR-BX-2012-030 and granting... COMMISSION Order Granting Application by Financial Industry Regulatory Authority, Inc. for Exemption...

  16. New dedicated AMS system at the Nuclear Regulatory Authority in Argentina

    Energy Technology Data Exchange (ETDEWEB)

    Beninson, D.; D' Amatto, E.; Oliveira, A.A.; Stark, J.W.; Bonino, N.O.; Bustos, G.R.; Alvarez, D.E.; Amodei, A.J.; Bonino, A.G.; Giannico, M.A.; Pomar, C. E-mail: cpomar@sede.arn.gov.ar

    2000-10-01

    At present, a new AMS system is being installed, at the Nuclear Regulatory Authority, in Argentina. The main goal of the system will be AMS assays of actinides in the area of nuclear safeguards. The installation of the facility started in January 1998. The present status of the project is described.

  17. [Post-authorization research, registries, and drug development].

    Science.gov (United States)

    Patarnello, Francesca; Recchia, Giuseppe

    2013-06-01

    In the last decade regulators, payers and health care providers tried to react to three major problems in drug development and drug use in clinical practice: the pharmaceutical R&D productivity crisis, the immaturity of benefit-risk profile for several newly approved drugs and the overall impact on economic sustainability of reimbursing new high cost drugs in their systems. The potentiality of create a continuum between the evidence requirements relevant for registration, for reimbursement and for post authorization research is clear. All different parties involved, like regulators, HTA agencies, scientific communities and manufacturers, are working to improve the knowledge profile of new drugs in order to anticipate the patient access to innovation, limiting or preventing the clinical and economical risks deriving from an incomplete safety and effectiveness profile. The Italian example of "New Drugs AIFA Registries", with or without the application of risk sharing schemes (cost sharing, pay for performance, etc.), introduced a new process and increased the sensitivity on this topic. However this might probably represents only a partial answer to the problem of how to set up the governance of coverage with evidence, drug utilization monitoring, comparative effectiveness research, outcome research programs and may be how to link them to access, pricing and reimbursement. The step change in post authorization research could be to "integrate" different sources and stakeholders in a wider and continuous approach, in a well designed and inclusive "second generation" HTA approach, where all resources (competencies, data, funding) will concur to increase the evidence profile and reduce the risks, and where any "evidence generation approach" is really compliant with the standard and rules of best research practices.

  18. [Regulatory Science in the Review of Drugs and Medical Devices].

    Science.gov (United States)

    Koide, Akihiro

    2016-01-01

    The review of drugs and medical devices is an integral part of regulatory science. The Pharmaceuticals and Medical Devices Agency (PMDA) evaluates the efficacy, safety, and quality of drugs and medical devices after applications are submitted for regulatory approval. The products are approved when their benefits exceed their risks, i.e., an application is approved if the efficacy of the product in patients was demonstrated and the safety of the product is acceptable in view of its observed benefits. However, drugs and medical devices for which efficacy was not clearly demonstrated in clinical trials makes the decision to approve a difficult process. Under those circumstances, the approval process is based on the totality of information, such as the reason why clinical trials did not succeed and medical needs in Japan. The Wingspan stent system, which was approved for the treatment of intracranial arterial stenosis, is an example of a product with a use different from that intended by the US Food and Drug Administration and PMDA.

  19. Regulatory aspects of small molecule drugs for heart regeneration.

    Science.gov (United States)

    Rodgers, Kathleen; Papinska, Anna; Mordwinkin, Nicholas

    2016-01-15

    Even though recent discoveries prove the existence of cardiac progenitor cells, internal regenerative capacity of the heart is minimal. As cardiovascular disease is the leading cause of deaths in the United States, a number of approaches are being used to develop treatments for heart repair and regeneration. Small molecule drugs are of particular interest as they are suited for oral administration and can be chemically synthesized. However, the regulatory process for the development of new treatment modalities is protracted, complex and expensive. One of the hurdles to development of appropriate therapies is the need for predictive preclinical models. The use of patient-derived cardiomyocytes from iPSC cells represents a novel tool for this purpose. Among other concepts for induction of heart regeneration, the most advanced is the combination of DPP-IV inhibitors with stem cell mobilizers. This review will focus on regulatory aspects as well as preclinical hurdles of development of new treatments for heart regeneration.

  20. Stability Testing of Herbal Drugs: Challenges, Regulatory Compliance and Perspectives.

    Science.gov (United States)

    Bansal, Gulshan; Suthar, Nancy; Kaur, Jasmeen; Jain, Astha

    2016-07-01

    Stability testing is an important component of herbal drugs and products (HDPs) development process. Drugs regulatory agencies across the globe have recommended guidelines for the conduct of stability studies on HDPs, which require that stability data should be included in the product registration dossier. From the scientific viewpoint, numerous chemical constituents in an herbal drug are liable to varied chemical reactions under the influence of different conditions during its shelf life. These reactions can lead to altered chemical composition of HDP and consequently altered therapeutic profile. Many reports on stability testing of HDPs have appeared in literature since the last 10 years. A review of these reports reveals that there is wide variability in temperature (-80 to 100 °C), humidity (0-100%) and duration (a few hours-36 months) for stability assessment of HDPs. Of these, only 1% studies are conducted in compliance with the regulatory guidelines for stability testing. The present review is aimed at compiling all stability testing reports, understanding key challenges in stability testing of HDPs and suggesting possible solutions for these. The key challenges are classified as chemical complexity and biochemical composition variability in raw material, selection of marker(s) and influences of enzymes. Copyright © 2016 John Wiley & Sons, Ltd.

  1. Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA)

    Science.gov (United States)

    do Carmo, Ana Cerúlia Moraes; Piras, Stefânia Schimaneski; Rocha, Nayrton Flávio Moura

    2017-01-01

    Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants to better organize the proposal. Methods. A retrospective search of drug products registration processes was performed on the Brazilian Government Official Gazette from January 1, 2015, and December 31, 2015. Results. Drug product quality control, drug product stability study, deadline accomplishment, API quality control made by drug manufacturer, active pharmaceutical ingredient (API), and production report were the main reasons for marketing authorization application refusal of generic and similar pharmaceutical drug products in 2015. Conclusion. Disclosure of the reasons behind failed applications is a step forward on regulatory transparency. Sharing of experiences is essential to international regulatory authorities and organizations to improve legislation requirements for the marketing authorization of generic and similar pharmaceutical drug products. PMID:28280742

  2. Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA).

    Science.gov (United States)

    do Carmo, Ana Cerúlia Moraes; Piras, Stefânia Schimaneski; Rocha, Nayrton Flávio Moura; Gratieri, Tais

    2017-01-01

    Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants to better organize the proposal. Methods. A retrospective search of drug products registration processes was performed on the Brazilian Government Official Gazette from January 1, 2015, and December 31, 2015. Results. Drug product quality control, drug product stability study, deadline accomplishment, API quality control made by drug manufacturer, active pharmaceutical ingredient (API), and production report were the main reasons for marketing authorization application refusal of generic and similar pharmaceutical drug products in 2015. Conclusion. Disclosure of the reasons behind failed applications is a step forward on regulatory transparency. Sharing of experiences is essential to international regulatory authorities and organizations to improve legislation requirements for the marketing authorization of generic and similar pharmaceutical drug products.

  3. Drug packaging in 2014: authorities should direct more efforts towards medication safety.

    Science.gov (United States)

    2015-05-01

    In 2014, Prescrire examined the packaging quality of about 250 drugs. A few advances stand out, mainly involving recent drugs, but on the whole, the situation is worrisome in terms of medication safety. Although pharmaceutical companies and drug regulatory agencies seem to be taking more account of the risk of accidental poisoning in children, the level of protection remains low overall in the absence of stringent measures on the part of the authorities. New drugs too often have poor-quality or even dangerous packaging at the time of their market introduction. And the packaging quality of older drugs is disturbing. Pharmaceutical companies no longer invest in the packaging of these products, and agencies often fail to take advantage of the opportunities provided by their reassessment to improve the situation. The inappropriate labelling of certain injectable drugs remains a source of medication errors, sometimes resulting in very serious consequences. In 2014, signs of progress in the packaging of several drugs show that its role in medication safety is better appreciated. But the persistence of dangers in the pharmaceuticals market, created by "unfinished", overly complex or poor-quality packaging, raises the question of the responsibility of pharmaceutical companies and agencies for past and present accidents.

  4. Evolving regulatory paradigm for proarrhythmic risk assessment for new drugs.

    Science.gov (United States)

    Vicente, Jose; Stockbridge, Norman; Strauss, David G

    Fourteen drugs were removed from the market worldwide because their potential to cause torsade de pointes (torsade), a potentially fatal ventricular arrhythmia. The observation that most drugs that cause torsade block the potassium channel encoded by the human ether-à-go-go related gene (hERG) and prolong the heart rate corrected QT interval (QTc) on the ECG, led to a focus on screening new drugs for their potential to block the hERG potassium channel and prolong QTc. This has been a successful strategy keeping torsadogenic drugs off the market, but has resulted in drugs being dropped from development, sometimes inappropriately. This is because not all drugs that block the hERG potassium channel and prolong QTc cause torsade, sometimes because they block other channels. The regulatory paradigm is evolving to improve proarrhythmic risk prediction. ECG studies can now use exposure-response modeling for assessing the effect of a drug on the QTc in small sample size first-in-human studies. Furthermore, the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative is developing and validating a new in vitro paradigm for cardiac safety evaluation of new drugs that provides a more accurate and comprehensive mechanistic-based assessment of proarrhythmic potential. Under CiPA, the prediction of proarrhythmic potential will come from in vitro ion channel assessments coupled with an in silico model of the human ventricular myocyte. The preclinical assessment will be checked with an assessment of human phase 1 ECG data to determine if there are unexpected ion channel effects in humans compared to preclinical ion channel data. While there is ongoing validation work, the heart rate corrected J-Tpeak interval is likely to be assessed under CiPA to detect inward current block in presence of hERG potassium channel block.

  5. Drug interaction studies on new drug applications: current situations and regulatory views in Japan.

    Science.gov (United States)

    Nagai, Naomi

    2010-01-01

    Drug interaction studies on new drug applications (NDAs) for new molecular entities (NMEs) approved in Japan between 1997 and 2008 are examined in the Pharmaceuticals and Medical Devices Agency (PMDA). The situations of drug interaction studies in NDAs have changed over the past 12 years, especially in metabolizing enzyme and transporter-based drug interactions. Materials and approaches to study drug-metabolizing enzyme-based drug interactions have improved, and become more rational based on mechanistic theory and new technologies. On the basis of incremental evidence of transporter roles in human pharmacokinetics, transporter-based drug interactions have been increasingly studied during drug development and submitted in recent NDAs. Some recently approved NMEs include transporter-based drug interaction information in their package inserts (PIs). The regulatory document "Methods of Drug Interaction Studies," in addition to recent advances in science and technology, has also contributed to plan and evaluation of drug interaction studies in recent new drug development. This review summarizes current situations and further discussion points on drug interaction studies in NDAs in Japan.

  6. Intercomparison run for uranium and tritium determination in urine samples, organised by Nuclear Regulatory Authority, Argentina

    CERN Document Server

    Serdeiro, N H; Equillor, H E

    2003-01-01

    The Nuclear Regulatory Authority (ARN), Argentina, has carried out an intercomparison run for tritium and uranium determination in urine, in November 2002. The aim of this exercise was to assess the performance of the laboratories that usually inform these radionuclides and to provide technical support in order to have an appropriate occupational monitoring in vitro. In the present work, the results of the intercomparison and the assessment of each laboratory are published.

  7. 25 CFR 547.17 - How does a tribal gaming regulatory authority apply for a variance from these standards?

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 2 2010-04-01 2010-04-01 false How does a tribal gaming regulatory authority apply for a variance from these standards? 547.17 Section 547.17 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT... CLASS II GAMES § 547.17 How does a tribal gaming regulatory authority apply for a variance from these...

  8. Hurdles in anticancer drug development from a regulatory perspective.

    Science.gov (United States)

    Jonsson, Bertil; Bergh, Jonas

    2012-02-21

    Between January 2001 and January 2012, 48 new medicinal products for cancer treatment were licensed within the EU, and 77 new indications were granted for products already licensed. In some cases, a major improvement to existing therapies was achieved, for example, trastuzumab in breast cancer. In other cases, new fields for effective drug therapy opened up, such as in chronic myeloid leukemia, and renal-cell carcinoma. In most cases, however, the benefit-risk balance was considered to be only borderline favorable. Based on our assessment of advice procedures for marketing authorization, 'need for speed' seems to be the guiding principle in anticancer drug development. Although, for drugs that make a difference, early licensure is of obvious importance to patients, this is less evident in the case of borderline drugs. Without proper incentives and with hurdles inside and outside companies, a change in drug development cannot be expected; drugs improving benefit-risk modestly over available therapies will be brought forward towards licensure. In this Perspectives article, we discuss some hurdles to biomarker-driven drug development and provide some suggestions to overcome them.

  9. Strategic Regulatory Evaluation and Endorsement of the Hollow Fiber Tuberculosis System as a Novel Drug Development Tool.

    Science.gov (United States)

    Romero, Klaus; Clay, Robert; Hanna, Debra

    2015-08-15

    The first nonclinical drug development tool (DDT) advanced by the Critical Path to TB Drug Regimens (CPTR) Initiative through a regulatory review process has been endorsed by leading global regulatory authorities. DDTs with demonstrated predictive accuracy for clinical and microbiological outcomes are needed to support decision making. Regulatory endorsement of these DDTs is critical for drug developers, as it promotes confidence in their use in Investigational New Drug and New Drug Application filings. The in vitro hollow fiber system model of tuberculosis (HFS-TB) is able to recapitulate concentration-time profiles (exposure) observed in patients for single drugs and combinations, by evaluating exposure measures for the ability to kill tuberculosis in different physiologic conditions. Monte Carlo simulations make this quantitative output useful to inform susceptibility breakpoints, dosage, and optimal combination regimens in patients, and to design nonclinical experiments in animal models. The Pre-Clinical and Clinical Sciences Working Group within CPTR executed an evidence-based evaluation of the HFS-TB for predictive accuracy. This extensive effort was enabled through the collaboration of subject matter experts representing the pharmaceutical industry, academia, product development partnerships, and regulatory authorities including the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A comprehensive analysis plan following the regulatory guidance documents for DDT qualification was developed, followed by individual discussions with the FDA and the EMA. The results from the quantitative analyses were submitted to both agencies, pursuing regulatory DDT endorsement. The EMA Qualification Opinion for the HFS-TB DDT was published 26 January 2015 (available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000319.jsp).

  10. Promise of new translational safety biomarkers in drug development and challenges to regulatory qualification.

    Science.gov (United States)

    Sistare, Frank D; DeGeorge, Joseph J

    2011-08-01

    One promise of new translational safety biomarkers (TSBs) is their ability to demonstrate that toxicities in animal studies are monitorable at an early stage, such that human relevance of potential adverse effects of drugs can be safely and definitively evaluated in clinical trials. Another is that they would provide an earlier, more definitive and deeper insight to patient prognosis compared with conventional biomarkers. Recent experience with regulatory authorities indicates that resource demands for new TSB qualifications under the current framework are daunting and the rate of their expansion will be slow, particularly in light of mounting financial pressures on the pharmaceutical industry. Sponsors face a dilemma over engaging in safety biomarker qualification consortia. While it is clear new TSBs could be considered catalysts to drug development and that patient health, business and scientific benefits, described here using examples, should outweigh qualification costs, concerns exist that early ambiguities in biomarker interpretations at the introduction of such new TSBs might hinder drug development.

  11. 77 FR 48491 - Regulatory New Drug Review: Solutions for Study Data Exchange Standards; Notice of Meeting...

    Science.gov (United States)

    2012-08-14

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I Regulatory New Drug Review: Solutions for... Administration (FDA) is announcing a meeting entitled ``Regulatory New Drug Review: Solutions for Study...

  12. 77 FR 57055 - Regulatory New Drug Review: Solutions for Study Data Exchange Standards; Notice of Meeting...

    Science.gov (United States)

    2012-09-17

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I Regulatory New Drug Review: Solutions for..., 2012 (77 FR 48491). The document announced a meeting entitled ``Regulatory New Drug Review:...

  13. Strategies of bringing drug product marketing applications to meet current regulatory standards.

    Science.gov (United States)

    Wu, Yan; Freed, Anita; Lavrich, David; Raghavachari, Ramesh; Huynh-Ba, Kim; Shah, Ketan; Alasandro, Mark

    2015-08-01

    In the past decade, many guidance documents have been issued through collaboration of global organizations and regulatory authorities. Most of these are applicable to new products, but there is a risk that currently marketed products will not meet the new compliance standards during audits and inspections while companies continue to make changes through the product life cycle for continuous improvement or market demands. This discussion presents different strategies to bringing drug product marketing applications to meet current and emerging standards. It also discusses stability and method designs to meet process validation and global development efforts.

  14. Comparison of bioequivalence study regulatory requirements for human and veterinary drugs.

    Science.gov (United States)

    Grabowski, Tomasz; Marczak, Monika; Jaroszewski, Jerzy Jan; Whitmire, Monica

    2012-11-01

    Guidelines published by the European Union Regulatory Authority, regarding the planning of bioequivalence studies, are the primary source of knowledge about the study design optimization. The goal of this paper is to compare the key elements (27 points) of bioequivalence study optimization based on a comparison of the two European Medicines Agency guidelines relating to medicines used for humans (HB) and to veterinary drugs (AB). In case of the latter, one can get the impression that the issues of species differences in relation to the physiology and anatomy have been completely ignored. Many details that the AB guideline omits are included in the new HB guideline and were present in many other guidelines from the last 20 years. Most have not been adopted by the AB document, even though they are the product of many years of work of many teams and specialists from various agencies in the regulatory affairs field.

  15. [Requirements for drug approval and additional benefits assessment: Regulatory aspects and experiences].

    Science.gov (United States)

    Broich, K; Löbker, W; Schulte, A; Beinlich, P; Müller, T

    2016-04-01

    The early assessment of benefits of newly approved drugs with novel active substances or new applications, which came into force on 1 January 2011 still represents a challenge to all parties involved. This article highlights the definitions, regulatory requirements and interaction between drug marketing approval and early assessment of benefits in Germany. The constellation of an extensively harmonized European and even international drug authorization process with a predominantly national regulation of drug reimbursement situation inevitably causes friction, which could be markedly reduced through early joint advisory discussions during the planning phase for pivotal clinical trials. During the year 2015 the Federal Institute for Drugs and Medical Devices (BfArM) carried out 300 scientific advice procedures of which 34 were concerned with applications in the field of indications for the central nervous system (CNS). In comparison 98 advisory meetings were held by the Federal Joint Committee (G-BA) of which the BfArM provided advice in 12 instances and in 2 cases on CNS indications. Study design, endpoints and appropriate comparative therapies are the key issues in exchanges and discussions between the BfArM, the G‑BA and applicants. Under these aspects the BfArM and G‑BA promote an early and consistent involvement in early advice procedures regarding the prerequisites for drug approval and assessment of additional benefits.

  16. Extent and content of data for regulatory submissions: First-in-human and marketing authorization--Viewpoint of US industry.

    Science.gov (United States)

    Harris, Ian Ross

    2015-09-01

    The amount and type of data in regulatory submissions increases dramatically from the first-in-human clinical trials application through to the extensive dossier that is required for marketing authorization. The Pharmaceuticals and Biotechnology industries are very familiar with the requirements and expectations of Health Authorities for small molecule and biologics, but have limited experience for cell-based therapies. Fortunately, the United States Food and Drug Administration (FDA) and European Medicines agency (EMA) Committee for Advanced Therapies (CAT) have considerable experience in regulating cell therapies and have provided extensive Guidance documents for developers. The Agencies offers advice to Sponsors through a variety of meetings. However, it is incumbent on the Sponsor to understand the regulations, interpret the Guidance documents and formulate clear company positions to enable the Agency to provide clear feedback. It is important for Sponsors to understand the factors that are critical for the safety and efficacy of their product and to demonstrate to the Health Authorities that they have a control strategy that ensures safety and efficacy during all stages of development. The focus of this paper is to describe some of the challenges for the chemistry manufacturing and controls (CMC) for cell therapies being development internationally.

  17. EU marketing authorization review of orphan and non-orphan drugs does not differ.

    Science.gov (United States)

    Putzeist, M; Mantel-Teeuwisse, A K; Llinares, J; Gispen-De Wied, C C; Hoes, A W; Leufkens, H G M

    2013-10-01

    Marketing authorization application dossiers of 17 orphan drugs (ODs) and 51 non-ODs evaluated by the European Medicines Agency (EMA) in the period 2009-2010 were compared. We aimed to identify whether any differences existed between ODs and non-ODs in number and type of deficits brought forward during the EMA review, regarding the clinical development plan, clinical outcome and medical need and studied whether these deficits were similarly associated with marketing approval in the EU. In 71% of the ODs dossiers and 65% of the non-ODs dossiers marketing approval was granted. Differences in deficits were found, but similarities in the way ODs and non-ODs were reviewed and marketing approval decisions were taken, underline that regulatory standards are equally high. Copyright © 2013 Elsevier Ltd. All rights reserved.

  18. [Haschish and heroine: considerations on interviews with drug addicts (author's transl)].

    Science.gov (United States)

    Foulon, L

    1979-01-01

    The author analyzes the phenomenological experience of drug in 48 drug addicts with haschisch or heroïne. The choice of the drug is linked to the severity and the type of suffering and the relationship between the drug addict and the drug is not necessarily self-destructive.

  19. 77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

    Science.gov (United States)

    2012-02-23

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  20. A clinical pharmacology-regulatory perspective on the approval of drugs for rare diseases.

    Science.gov (United States)

    Bashaw, E D

    2016-10-01

    Orphan drugs or drugs for rare diseases represents a particular regulatory conundrum. There is a desperate need for effective therapies for these patients, who have been historically underserved by the drug development community. However, there is also a need to make sure these therapies are both safe and effective. In response, the US Food and Drug Administration (FDA) has evolved new approaches to facilitate drug development in this area.

  1. 78 FR 27113 - Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Public Hearing; Request...

    Science.gov (United States)

    2013-05-09

    ... FY 2013 Regulatory Science Plan consisted of the following research topics: 1. Bioequivalence of local acting, orally inhaled drug products 2. Bioequivalence of local acting topical dermatological drug products 3. Bioequivalence of local acting gastrointestinal drug products 4. Quality by design of...

  2. Assessment of Safety Culture within the Pakistan Nuclear Regulatory Authority (PNRA)

    Energy Technology Data Exchange (ETDEWEB)

    Afzal, Muhammad [Pakistan Nuclear Regulatory Authority, Islamabad (Pakistan); Choi, Kwang Sik [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2015-10-15

    The objective of this study is to assess the SC of the Pakistan Nuclear Regulatory Authority (PNRA) by developing a performance indicator-based questionnaire. Aspects that potentially play important roles in developing perceptions of SC, including age, type of job, gender and duty hours of regulatory staff, are given due importance in this study. The study also identifies the strengths and weaknesses in the SC of the PNRA and can be used as a model study to assess the SC of other RBs. The questionnaire, developed to assess the SC of the PNRA, was in line with the PNRA's own defined attributes for SC. In the past, significant efforts have been made to ensure the safe operation of NPPs by improving designs and operating procedures; however, the nuclear accident at the Fukushima NPP in Japan in March 2011 revealed that the currently allotted hardware safety margins are not sufficient, and much work is needed to improve safety management in terms of SC. Initially, the concept of SC was introduced for operating organizations to ensure safe operation of NPPs; nonetheless, more recent investigations of nuclear events and accidents, especially Fukushima, and at Davis-Besse, in the US, have revealed that a strong focus is required to address and improve the SC of Regulatory Bodies (RBs). Strong SC is considered a vital tool for RBs to achieve their objectives and discharge their responsibilities in an effective and efficient manner. Though the relationship between the SC of RBs and that of operating organizations is not straight forward, it is believed that the former has a strong influence over the latter. The questionnaire was consistent in terms of the credible nature of its questions, and the response group covered different levels of PNRA staff, from managers to lower level staff. The results show that the PNRA staff have a very good understanding of the nature and significance of attributes of SC and are doing their best to exercise the same within the

  3. Clinical pharmacology of tyrosine kinase inhibitors becoming generic drugs: the regulatory perspective.

    Science.gov (United States)

    Eckstein, Niels; Röper, Lea; Haas, Bodo; Potthast, Henrike; Hermes, Ulrike; Unkrig, Christoph; Naumann-Winter, Frauke; Enzmann, Harald

    2014-02-07

    Over the last decades, billions have been spent and huge efforts have been taken in basic and clinical cancer research [CA Cancer J Clin63:11-30]. About a decade ago, the arms race between drugs and cancer cells reached a new level by introduction of tyrosine kinase inhibitors (TKI) into pharmacological anti-cancer therapy. According to their molecular mechanism of action, TKI in contrast to so-called "classic" or "conventional" cytostatics belong to the group of targeted cancer medicines, characterized by accurately fitting with biological structures (i.e. active centers of kinases). Numerous (partly orphan) indications are covered by this new class of substances. Approximately ten years after the first substances of this class of medicines were authorized, patent protection will end within the next years. The following article covers clinical meaning and regulatory status of anti-cancer TKI and gives an outlook to what is expected from the introduction of generic anti-cancer TKI.

  4. The planning, construction, and operation of a radioactive waste storage facility for an Australian state radiation regulatory authority

    Energy Technology Data Exchange (ETDEWEB)

    Wallace, J.D.; Kleinschmidt, R.; Veevers, P. [Radiation Health, Queensland (Australia)

    1995-12-31

    Radiation regulatory authorities have a responsibility for the management of radioactive waste. This, more often than not, includes the collection and safe storage of radioactive sources in disused radiation devices and devices seized by the regulatory authority following an accident, abandonment or unauthorised use. The public aversion to all things radioactive, regardless of the safety controls, together with the Not In My Back Yard (NIMBY) syndrome combine to make the establishment of a radioactive materials store a near impossible task, despite the fact that such a facility is a fundamental tool for regulatory authorities to provide for the radiation safety of the public. In Queensland the successful completion and operational use of such a storage facility has taken a total of 8 years of concerted effort by the staff of the regulatory authority, the expenditure of over $2 million (AUS) not including regulatory staff costs and the cost of construction of an earlier separate facility. This paper is a summary of the major developments in the planning, construction and eventual operation of the facility including technical and administrative details, together with the lessons learned from the perspective of the overall project.

  5. Nuclear Regulatory Authority low energy germanium detection system: performance for the uranium individual monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Spinella, M.R.; Krimer, M.; Rojo, A.M.; Gregori, B.N. [Autoridad Regulatoria Nuclear, Avda. del Libertador 8250, (C1429BNP) Ciudad Autonoma de Buenos Aires (Argentina); Gomez Parada, I. [Sociedad Argentina de Radioproteccion, Avda. del Libertador 8250, (C1429BNP) Ciudad Autonoma de Buenos Aires (Argentina)

    2007-07-01

    The lung counter facility of the Nuclear Regulatory Authority (ARN) is presented. A calibration was carried out using the Lawrence Livermore National Laboratory (LLNL) phantom. This phantom is provided with a pair of lungs and lymph nodes containing uranium homogeneously distributed and a set of four overlay plates covering a chest wall thickness (CWT) ranging from 1.638 to 3.871 cm. Individual organ calibration factors were acquired for {sup 235}U photo-peaks energies and for each effective chest thickness. Using these factors, a collection of theoretical fitting curves were found. A counting efficiency formulae and a curve for simultaneously active lymph nodes and lung was obtained and checked through measures. Background measurements of the chamber with and without volunteer persons were performed in order to obtain the detection limits (DL) of the system. As this task involves the knowledge of the volunteers CWTs, these magnitudes were determined through formulae selected from the literature taking into account the detection system characteristics. The deviation in the CWT assigned to an individual, generated by applying different equations, produces variations up to 33% in the estimations of the incorporated activity and DL. An analysis of the changes in efficiencies as consequences of the detectors locations and CWT was also performed. This reveals that the DL of the camera (detectors, shield and blank phantom) is between 2.7 and 6.4 Bq of {sup 235}U, which implies 4.9 and 11.5 mg lung burden of natural uranium. An estimation of the minimum detectable intake performed with the DL considering blank persons shows that a system with the characteristics described is only adequate for non-routine individual monitoring. (authors)

  6. Substate federalism and fracking policies: does state regulatory authority trump local land use autonomy?

    Science.gov (United States)

    Davis, Charles

    2014-01-01

    State officials responsible for the regulation of hydraulic fracturing (fracking) operations used in the production of oil and gas resources will inevitably confront a key policy issue; that is, to what extent can statewide regulations be developed without reducing land use autonomy typically exercised by local officials? Most state regulators have historically recognized the economic importance of industry jobs and favor the adoption of uniform regulatory requirements even if these rules preempt local policymaking authority. Conversely, many local officials seek to preserve land use autonomy to provide a greater measure of protection for public health and environmental quality goals. This paper examines how public officials in three states-Colorado, Pennsylvania, and Texas-address the question of state control versus local autonomy through their efforts to shape fracking policy decisions. While local officials within Texas have succeeded in developing fracking ordinances with relatively little interference from state regulators, Colorado and Pennsylvania have adopted a tougher policy stance favoring the retention of preemptive oil and gas statutes. Key factors that account for between state differences in fracking policy decisions include the strength of home rule provisions, gubernatorial involvement, and the degree of local experience with industrial economic activities.

  7. [European Union regulatory and quality requirements for botanical drugs and their implications for Chinese herbal medicinal products development].

    Science.gov (United States)

    Zhu, You-Ping

    2017-06-01

    This paper introduces regulatory pathways and characteristic quality requirements for marketing authorization of herbal medicinal products in the European Union(EU), and the legal status and applications of "European Union list of herbal substances, preparations and combinations" and "European Union herbal monographs". Also introduced are Chinese herbs that have been granted the EU list entry, those with EU herbal monographs, and registered EU traditional herbal medicinal products with Chinese herbs as active ingredients. Special attention is paid to the technical details of three authorized EU herbal medicinal products (Veregen, Sativex and Episalvan) in comparison with Andrographis paniculata extract HMPL-004 that failed the phase Ⅲ clinical trial for ulcerative colitis. The paper further emphasizes the importance of enriching active fractions of herbal extracts and taking regulatory and quality considerations into account in early stage of botanical drug development. Copyright© by the Chinese Pharmaceutical Association.

  8. An epidemiological analysis of equine welfare data from regulatory inspections by the official competent authorities.

    Science.gov (United States)

    Hitchens, P L; Hultgren, J; Frössling, J; Emanuelson, U; Keeling, L J

    2016-12-09

    welfare if they also complied with documentation requirements. We present a novel approach for analysis of equine welfare data from regulatory inspections by the official competent authorities, and propose on-going analyses and benchmarking of trends in animal-based measures over time. We also suggest how such a database could be further improved to facilitate future epidemiological analyses of risk factors associated with poor equine welfare. The study has implications for other competent authorities and researchers collaborating in the area of animal welfare epidemiology.

  9. 25 CFR 547.4 - How does a tribal government, tribal gaming regulatory authority, or tribal gaming operation...

    Science.gov (United States)

    2010-04-01

    ... number and the date of manufacture or a statement that the date of manufacture was on or before the... to: (i) Immediately advise other users of the same hardware or software of the importance and... its integrity, independence and financial stability to the tribal gaming regulatory authority. (ii)...

  10. Use of probabilistic safety assessment in supporting regulatory authority`s work; Todennaekoeisyyspohjaisen turvallisuusanalyysin kaeyttoe viranomaistyoen tukena

    Energy Technology Data Exchange (ETDEWEB)

    Julin, A.

    1995-11-01

    The aim of the study was to examine possibilities to use probabilistic safety assessment (PSA) more effectively in regulatory control of nuclear power plants. The structure, results and evaluation methods of PSA along with the necessary equations and principles, which could be used in utilising level 1 PSA results in decision making, have been introduced. The presented examples describe the ways PSA has been utilised abroad and particularly in Finnish Centre for Radiation and Nuclear Safety (STUK). The examples calculated in the study are based on the SPSA code and the PSA model of Olkiluoto nuclear power plant (TVO). The examples compare component safety classes versus safety importance and the risk of continued operation versus shutdown alternative in residual heat removal system failures. In addition to this allowed outage times, as calculated by PSA, were compared to allowed outage times according to technical specifications. The last 9 years operating experiences of TVO II was also examined by analysing the risk importance of significant component failures and operational disturbances. The analysis showed that the contribution of component failures and operational disturbances to the overall core damage risk during the studied time period was only 5 per cent. It appeared that the rare, significant initiating events provide the main contribution to the total cumulative risk. (57 refs., 22 figs., 17 tabs.).

  11. Present and future breast cancer management--bench to bedside and back: a positioning paper of academia, regulatory authorities and pharmaceutical industry

    National Research Council Canada - National Science Library

    Bartsch, R; Frings, S; Marty, M; Awada, A; Berghoff, A S; Conte, P; Dickin, S; Enzmann, H; Gnant, M; Hasmann, M; Hendriks, H R; Llombart, A; Massacesi, C; von Minckwitz, G; Penault-Llorca, F; Scaltriti, M; Yarden, Y; Zwierzina, H; Zielinski, C C

    2014-01-01

    .... An expert panel representing the academic community, the pharmaceutical industry, as well as European Regulatory Authorities met in Vienna, Austria, in November 2012, in order to discuss breast...

  12. Analytical Strategies for Drug Residues in Various Matrices in a Regulatory Laboratory.

    OpenAIRE

    Dowling, Geraldine

    2012-01-01

    Abstract Today, in modern farming practices veterinary drugs are given to food-producing animals. The generic term “veterinary drugs” covers a broad variety of classes of chemical compounds and the list of drugs is enormous and it is a significant analytical challenge in regulatory control to provide monitoring programmes. The major concerns in veterinary drug usage are the presence of harmful residues that may be introduced into the human food chain. The aim of this research is the develo...

  13. Analytical Strategies for Drug Residues in Various Matrices in a Regulatory Laboratory.

    OpenAIRE

    Dowling, Geraldine

    2012-01-01

    Abstract Today, in modern farming practices veterinary drugs are given to food-producing animals. The generic term “veterinary drugs” covers a broad variety of classes of chemical compounds and the list of drugs is enormous and it is a significant analytical challenge in regulatory control to provide monitoring programmes. The major concerns in veterinary drug usage are the presence of harmful residues that may be introduced into the human food chain. The aim of this research is the develo...

  14. Regulatory framework for the availability and use of animal drugs in the United States.

    Science.gov (United States)

    Modric, Sanja

    2013-09-01

    The goal of this article is to help practitioners understand the regulatory framework and basis for the approval of new animal drugs, the terminology and specific meaning of terms related to drug approval, and the marketing and use of veterinary drugs in companion animal practice. Understanding the differences between approved versus unapproved drugs and their use helps practitioners make the appropriate clinical decisions on their patients' treatment. Only when buying approved animal drugs can clinicians be assured of product safety, effectiveness, and manufacturing to the strict standards for quality, purity, and potency, as well as truthful and complete labeling.

  15. Drug-drug interactions related to altered absorption and plasma protein binding: theoretical and regulatory considerations, and an industry perspective.

    Science.gov (United States)

    Hochman, Jerome; Tang, Cuyue; Prueksaritanont, Thomayant

    2015-03-01

    Drug-drug interactions (DDIs) related to altered drug absorption and plasma protein binding have received much less attention from regulatory agencies relative to DDIs mediated via drug metabolizing enzymes and transporters. In this review, a number of theoretical bases and regulatory framework are presented for these DDI aspects. Also presented is an industry perspective on how to approach these issues in support of drug development. Overall, with the exception of highly permeable and highly soluble (BCS 1) drugs, DDIs related to drug-induced changes in gastrointestinal (GI) physiology can be substantial, thus warranting more attentions. For a better understanding of absorption-associated DDI potential in a clinical setting, mechanistic studies should be conducted based on holistic integration of the pharmaceutical profiles (e.g., pH-dependent solubility) and pharmacological properties (e.g., GI physiology and therapeutic margin) of drug candidates. Although majority of DDI events related to altered plasma protein binding are not expected to be of clinical significance, exceptions exist for a subset of compounds with certain pharmacokinetic and pharmacological properties. Knowledge of the identity of binding proteins and the binding extent in various clinical setting (including disease states) can be valuable in aiding clinical DDI data interpretations, and ensuring safe and effective use of new drugs.

  16. Progress, innovation and regulatory science in drug development: the politics of international standard-setting.

    Science.gov (United States)

    Abraham, John; Reed, Tim

    2002-06-01

    This paper examines international standard-setting in the toxicology of pharmaceuticals during the 1990s, which has involved both the pharmaceutical industry and regulatory agencies in an organization known as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The analysis shows that the relationships between innovation, regulatory science and 'progress' may be more complex and controversial than is often assumed. An assessment of the ICH's claims about the implications of 'technical' harmonization of drug-testing standards for the maintenance of drug safety, via toxicological testing, and the delivery of therapeutic progress, via innovation, is presented. By demonstrating that there is not a technoscientific validity for these claims, it is argued that, within the ICH, a discourse of technological innovation and scientific progress has been used by regulatory agencies and prominent parts of the transnational pharmaceutical industry to legitimize the lowering and loosening of toxicological standards for drug testing. The mobilization and acceptance of this discourse are shown to be pivotal to the ICH's transformation of reductions in safety standards, which are apparently against the interests of patients and public health, into supposed therapeutic benefits derived from promises of greater access to more innovative drug products. The evidence suggests that it is highly implausible that these reductions in the standards of regulatory toxicology are consistent with therapeutic progress for patients, and highlights a worrying aspect embedded in the 'technical trajectories' of regulatory science.

  17. An Update of the Brazilian Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug Products.

    Science.gov (United States)

    Soares, Kelen Carine Costa; Santos, Gustavo Mendes Lima; Gelfuso, Guilherme M; Gratieri, Tais

    2015-11-01

    This note aims to clarify the Brazilian regulatory bioequivalence recommendations for approval of generic topical dermatological drug products, since the legal framework of the "Brazilian Health Surveillance Agency" (ANVISA) is only available in Portuguese. According to Resolutions RE n. 1170 (December 19th 2006) and RDC n. 37 (August 3rd 2011) in Brazil, only in vitro studies are required for registration of generic topical dermatological drug products. Current Regulatory Agenda of ANVISA, which contains possible future resolutions to be revised over 2015-2016, includes a discussion on biowaiver requirements and on possible in vitro and in vivo comparability tests for these products.

  18. 78 FR 15953 - Cooperative Agreement To Support Regulatory Research Related to Food and Drug Administration...

    Science.gov (United States)

    2013-03-13

    ... new innovative initiatives related to virtually every aspect of the new drug life cycle, each of which... efforts and methods that have been applied to structure and communicate regulatory decisions, including... organization is eligible to apply: ECHCR. Within the Brookings Institution, the mission of the ECHCR is...

  19. Implementation of in vitro replacement technologies in regulatory drug testing - An innovation systems perspective

    NARCIS (Netherlands)

    Kooijman, M.; Van Meer, P.J.K.; Moors, E.H.M.; Hekkert, M.P.; Schellekens, H.

    2011-01-01

    The replacement of in vivo methods by in vitro methods in regulatory drug testing is rare. The aim of this research is to identify barriers and drivers of the replacement of in vivo methods by in vitro methods in Europe. We studied two cases. The first case is the Draize eye test. Since 2009, the in

  20. Implementation of in vitro replacement technologies in regulatory drug testing - An innovation systems perspective

    NARCIS (Netherlands)

    Kooijman, M.; Van Meer, P.J.K.; Moors, E.H.M.; Hekkert, M.P.; Schellekens, H.

    2011-01-01

    The replacement of in vivo methods by in vitro methods in regulatory drug testing is rare. The aim of this research is to identify barriers and drivers of the replacement of in vivo methods by in vitro methods in Europe. We studied two cases. The first case is the Draize eye test. Since 2009, the in

  1. Limits of the current EU regulatory framework on GMOs: risk of not authorized GM event-traces in imports

    Directory of Open Access Journals (Sweden)

    Roïz Julie

    2014-11-01

    Full Text Available Since their first commercialization in the 1990’s, the number of genetically modified organisms (GMOs cultivated around the world has steadily increased. This development has been accompanied by the development of regulatory and policy environments which vary from one country to another. Today, the European food and feed sectors are faced with the increasing risk of finding traces of not authorized GMOs in imports. Under the EU zero tolerance for unapproved GMOs, this situation may lead to trade disruptions with important cost implications. A regulatory environment which minimizes the risk of such disruption is therefore indispensable. To address this issue, the EU has adopted the “technical solution” but this remains insufficient to provide the necessary legal certainty which is needed to operate in such context. More comprehensive approaches are considered globally through low level presence policies.

  2. The role of quantitative safety evaluation in regulatory decision making of drugs.

    Science.gov (United States)

    Chakravarty, Aloka G; Izem, Rima; Keeton, Stephine; Kim, Clara Y; Levenson, Mark S; Soukup, Mat

    2016-01-01

    Evaluation of safety is a critical component of drug review at the US Food and Drug Administration (FDA). Statisticians are playing an increasingly visible role in quantitative safety evaluation and regulatory decision-making. This article reviews the history and the recent events relating to quantitative drug safety evaluation at the FDA. The article then focuses on five active areas of quantitative drug safety evaluation and the role Division of Biometrics VII (DBVII) plays in these areas, namely meta-analysis for safety evaluation, large safety outcome trials, post-marketing requirements (PMRs), the Sentinel Initiative, and the evaluation of risk from extended/long-acting opioids. This article will focus chiefly on developments related to quantitative drug safety evaluation and not on the many additional developments in drug safety in general.

  3. Improving the assessment of heart toxicity for all new drugs through translational regulatory science.

    Science.gov (United States)

    Johannesen, L; Vicente, J; Gray, R A; Galeotti, L; Loring, Z; Garnett, C E; Florian, J; Ugander, M; Stockbridge, N; Strauss, D G

    2014-05-01

    Fourteen drugs have been removed from the market worldwide because they cause torsade de pointes. Most drugs that cause torsade can be identified by assessing whether they block the human ether à gogo related gene (hERG) potassium channel and prolong the QT interval on the electrocardiogram. In response, regulatory agencies require new drugs to undergo "thorough QT" studies. However, some drugs block hERG potassium channels and prolong QT with minimal torsade risk because they also block calcium and/or sodium channels. Through analysis of clinical and preclinical data from 34 studies submitted to the US Food and Drug Administration and by computer simulations, we demonstrate that by dividing the QT interval into its components of depolarization (QRS), early repolarization (J-Tpeak), and late repolarization (Tpeak-Tend), along with atrioventricular conduction delay (PR), it may be possible to determine which hERG potassium channel blockers also have calcium and/or sodium channel blocking activity. This translational regulatory science approach may enable innovative drugs that otherwise would have been labeled unsafe to come to market.

  4. Bioequivalence study designs for generic solid oral anticancer drug products: scientific and regulatory considerations.

    Science.gov (United States)

    Kaur, Paramjeet; Chaurasia, Chandra S; Davit, Barbara M; Conner, Dale P

    2013-12-01

    The demonstration of bioequivalence (BE) between the test and reference products is an integral part of generic drug approval process. A sound BE study design is pivotal to the successful demonstration of BE of generic drugs to their corresponding reference listed drug product. Generally, BE of systemically acting oral dosage forms is demonstrated in a crossover, single-dose in vivo study in healthy subjects. The determination of BE of solid oral anticancer drug products is associated with its own unique challenges due to the serious safety risks involved. Unlike typical BE study in healthy subjects, the safety issues often necessitate conducting BE studies in cancer patients. Such BE studies of an anticancer drug should be conducted without disturbing the patients' therapeutic dosing regimen. Attributes such as drug permeability and solubility, pharmacokinetics, dosing regimen, and approved therapeutic indication(s) are considered in the BE study design of solid anticancer drug products. To streamline the drug approval process, the Division of Bioequivalence posts the Bioequivalence Recommendations for Specific Products guidances on the FDA public website. The objective of this article is to illustrate the scientific and regulatory considerations in the design of BE studies for generic solid oral anticancer drug products through examples.

  5. Comparison of outcomes following a switch from a brand to an authorized vs. independent generic drug.

    Science.gov (United States)

    Hansen, Richard A; Qian, Jingjing; Berg, Richard L; Linneman, James G; Seoane-Vazquez, Enrique; Dutcher, Sarah; Raofi, Saeid; Page, C David; Peissig, Peggy L

    2016-12-16

    Authorized generics are identical in formulation to brand drugs, manufactured by the brand company but marketed as a generic. Generics, marketed by generic manufacturers, are required to demonstrate pharmaceutical and bioequivalence to the brand drug, but repetition of clinical trials is not required. This retrospective cohort study compared outcomes for generics and authorized generics, which serves as a generic vs. brand proxy that minimizes bias against generics. For the seven drugs studied between 1999-2014, 5,234 unique patients were on brand drug prior to generic entry and 4,900 (93.6%) switched to a generic. During the 12-months following the brand-to-generic switch, patients using generics vs. authorized generics were similar in terms of outpatient visits, urgent care visits, hospitalizations, and medication discontinuation. The likelihood of emergency department visits was slightly higher for authorized generics compared with generics. These data suggest that generics were clinically no worse than their proxy brand comparator. This article is protected by copyright. All rights reserved.

  6. Governmental oversight of prescribing medications: history of the US Food and Drug Administration and prescriptive authority.

    Science.gov (United States)

    Plank, Linda S

    2011-01-01

    The evolution of drug regulation and awarding of prescriptive authority is a complex and sometimes convoluted process that can be confusing for health care providers. A review of the history of how drugs have been manufactured and dispensed helps explain why this process has been so laborious and complicated. Because the federal and state governments have the responsibility for protecting the public, most regulations have been passed with the intentions of ensuring consumer safety. The current system of laws and regulations is the result of many years of using the legal system to correct drug marketing that had adverse health consequences. Government oversight will continue as prescribing medications transitions to an electronic form and as health care professionals in addition to physicians seek to gain prescriptive authority.

  7. Genome-wide discovery of drug-dependent human liver regulatory elements.

    Directory of Open Access Journals (Sweden)

    Robin P Smith

    2014-10-01

    Full Text Available Inter-individual variation in gene regulatory elements is hypothesized to play a causative role in adverse drug reactions and reduced drug activity. However, relatively little is known about the location and function of drug-dependent elements. To uncover drug-associated elements in a genome-wide manner, we performed RNA-seq and ChIP-seq using antibodies against the pregnane X receptor (PXR and three active regulatory marks (p300, H3K4me1, H3K27ac on primary human hepatocytes treated with rifampin or vehicle control. Rifampin and PXR were chosen since they are part of the CYP3A4 pathway, which is known to account for the metabolism of more than 50% of all prescribed drugs. We selected 227 proximal promoters for genes with rifampin-dependent expression or nearby PXR/p300 occupancy sites and assayed their ability to induce luciferase in rifampin-treated HepG2 cells, finding only 10 (4.4% that exhibited drug-dependent activity. As this result suggested a role for distal enhancer modules, we searched more broadly to identify 1,297 genomic regions bearing a conditional PXR occupancy as well as all three active regulatory marks. These regions are enriched near genes that function in the metabolism of xenobiotics, specifically members of the cytochrome P450 family. We performed enhancer assays in rifampin-treated HepG2 cells for 42 of these sequences as well as 7 sequences that overlap linkage-disequilibrium blocks defined by lead SNPs from pharmacogenomic GWAS studies, revealing 15/42 and 4/7 to be functional enhancers, respectively. A common African haplotype in one of these enhancers in the GSTA locus was found to exhibit potential rifampin hypersensitivity. Combined, our results further suggest that enhancers are the predominant targets of rifampin-induced PXR activation, provide a genome-wide catalog of PXR targets and serve as a model for the identification of drug-responsive regulatory elements.

  8. Comprehensive analysis of clinical development and regulatory submission promotion schemes for oncologic drugs as the Japanese national projects.

    Science.gov (United States)

    Nagai, Sumimasa; Ozawa, Keiya

    2016-12-01

    To reduce the delay in marketing authorization of drugs in Japan, four Japanese national projects were instituted. We examined all oncologic drugs for adult patients approved or discussed through these schemes, for the first time. All the data are publicly available. In total, 197 applications/demands (181 indications and 16 dosages/uses) were collected. As of December 31, 2015, 64 indications and 10 dosages/uses were approved as off-label drugs through these schemes without conducting additional registration trials in Japan. Furthermore, 46 indications and two dosages/uses were approved after registration trials in Japan requested by the national scheme councils. Regarding the following 23 indications of the 197 applications/demands, registration trials in Japan were commenced after the national scheme council's request: 17 hematological malignancies and six orphan solid tumors. Moreover, 54 indications and three dosages/uses, for which demands were submitted, were regarded as not a high medical priority by the national scheme council. Regarding two hematological malignancy indications, the dosage approved in foreign countries was intolerable for the Japanese patients in Japanese registration trials and this stopped the clinical development in Japan. Our analysis showed that 110 indications and 12 dosages/uses were approved in Japan through these schemes. These national projects have provided numerous therapeutic options for Japanese patients and may be meaningful for promoting clinical development and regulatory approval especially in orphan diseases in countries other than Japan.

  9. Causality Assessment in Premarketing Drug Clinical Trials: Regulatory Evolution in the USA and Ongoing Concerns.

    Science.gov (United States)

    Goldman, Stephen A

    2016-10-01

    Since 1993, how to assess the causality of serious adverse events in premarketing drug clinical trials has undergone sustained regulatory evolution in the USA. In that year, an investigational drug study for chronic hepatitis B virus infection was emergently stopped after a patient suddenly exhibited hepatic failure and lactic acidosis, which later developed, along with pancreatitis and peripheral neuropathy, in several others after drug discontinuation. Five patients eventually died, including three despite emergency liver transplantation. The drug's multisystem toxicity was not predicted by preclinical animal studies, with grave injury to human mitochondria subsequently implicated. A concerned US Food and Drug Administration (FDA) created a task force whose findings would have a lasting impact on the agency's thinking. In 1994, the FDA proposed to amend its investigational new drug reporting requirements largely based on task force recommendations for ways to enhance the likelihood that sponsors and investigators would consider investigational agents as a possible cause of serious adverse events mimicking the underlying disease or concomitant drug toxicity. Then, in its 1997 final rule for expedited safety reporting requirements for drugs and biologics, the FDA advised sponsors that such reporting of serious, unexpected clinical trial cases would be expected when "there is a reasonable suspected causal relationship between the investigational product and the adverse event (i.e., the causal relationship cannot be ruled out)." This last clause was codified into the suspected adverse drug reaction definition in the FDA's 2003 safety reporting requirements for drugs and biologics proposed rule. The negatively received suspected adverse drug reaction and proposed causality standard were not adopted in the FDA's 2010 finalized investigational new drug safety reporting regulations, the agency stating that "'reasonable possibility' means there is evidence to suggest a

  10. Optimal Control of Gene Regulatory Networks with Effectiveness of Multiple Drugs: A Boolean Network Approach

    Science.gov (United States)

    Kobayashi, Koichi; Hiraishi, Kunihiko

    2013-01-01

    Developing control theory of gene regulatory networks is one of the significant topics in the field of systems biology, and it is expected to apply the obtained results to gene therapy technologies in the future. In this paper, a control method using a Boolean network (BN) is studied. A BN is widely used as a model of gene regulatory networks, and gene expression is expressed by a binary value (0 or 1). In the control problem, we assume that the concentration level of a part of genes is arbitrarily determined as the control input. However, there are cases that no gene satisfying this assumption exists, and it is important to consider structural control via external stimuli. Furthermore, these controls are realized by multiple drugs, and it is also important to consider multiple effects such as duration of effect and side effects. In this paper, we propose a BN model with two types of the control inputs and an optimal control method with duration of drug effectiveness. First, a BN model and duration of drug effectiveness are discussed. Next, the optimal control problem is formulated and is reduced to an integer linear programming problem. Finally, numerical simulations are shown. PMID:24058904

  11. Reflections on the role of the pharmacy regulatory authority in enhancing quality related event reporting in community pharmacies.

    Science.gov (United States)

    Boyle, Todd A; Bishop, Andrea C; Mahaffey, Thomas; Mackinnon, Neil J; Ashcroft, Darren M; Zwicker, Bev; Reid, Carolyn

    2014-01-01

    Given the demanding nature of providing pharmacy services, coupled with the expanded scope of practice of the professions in jurisdictions around the world, greater commitment to continuous quality improvement through adoption of quality-related event (QRE) reporting is necessary to ensure patient safety. Pharmacy regulatory authorities (PRAs) are in a unique position to enhance QRE reporting and learning through the standardization of expected practice. This study was aimed to gain a better understanding of the perceived roles of PRAs in enhancing QRE reporting and learning in community pharmacies, and identifying regulatory best practices to execute such roles. A purposive case sampling approach was used to identify PRA staff members from two groups (Deputy registrars and pharmacy inspectors) in 10 Canadian jurisdictions to participate in focus groups in the fall of 2011. Focus groups were used to explore perceptions of the role of PRAs in enhancing and promoting QRE reporting and learning, and perceived barriers to effective implementation in practice. Thematic analysis was used to analyze the qualitative data. Two focus groups were conducted, one with seven Deputy registrars/Practice managers, and one with nine pharmacy inspectors. Five themes were identified, including (1) defining QRE reporting and compliance, (2) navigating role conflict, (3) educating for enhanced QRE reporting and learning, (4) promoting the positive/removing the fear of QREs, and (5) tailoring QRE reporting and learning consistency. Overall, participants perceived a strong role for PRAs in enhancing QRE reporting and learning and providing education for pharmacies to support their compliance with reporting standards. However, PRAs must navigate the conflict inherent in both educating and promoting a process for achieving a standard while simultaneously inspecting compliance to that standard. Ensuring pharmacies have autonomy in operationalizing standards may help to mitigate this conflict

  12. REFLECTIONS ON THE ROLE OF THE PHARMACY REGULATORY AUTHORITY IN ENHANCING QUALITY RELATED EVENT REPORTING IN COMMUNITY PHARMACIESi

    Science.gov (United States)

    Boyle, Todd A.; Bishop, Andrea C.; Mahaffey, Thomas; MacKinnon, Neil J.; Ashcroft, Darren; Zwicker, Bev; Reid, Carolyn

    2016-01-01

    Background Given the demanding nature of providing pharmacy services, coupled with the expanded scope of practice of the professions in jurisdictions around the world, greater commitment to continuous quality improvement through adoption of quality related event (QRE) reporting is necessary to ensure patient safety. Pharmacy regulatory authorities (PRAs) are in a unique position to enhance QRE reporting and learning through the standardization of expected practice Objective This study aims to better understand the perceived roles of PRAs in enhancing QRE reporting and learning in community pharmacies and identifying regulatory best practices to execute such roles. Methods A purposive case sampling approach was used to identify PRA staff members from two groups (deputy registrars and pharmacy inspectors) in 10 Canadian jurisdictions to participate in focus groups in the fall of 2011. Focus groups were used to explore perceptions of the role of PRAs in enhancing and promoting QRE reporting and learning, and perceived barriers to effective implementation in practice. Thematic analysis was used to analyze the qualitative data. Results Two focus groups were conducted, one with seven deputy registrars/practice managers and one with nine pharmacy inspectors. Five themes were identified, including (1) defining QRE reporting and compliance, (2) navigating role conflict, (3) educating for enhanced QRE reporting and learning, (4) promoting the positive/removing the fear of QREs, and (5) tailoring QRE reporting and learning consistency. Conclusions Overall, participants perceived a strong role for PRAs in enhancing QRE reporting and learning and providing education for pharmacies to support their compliance with reporting standards. However, PRAs must navigate the conflict inherent in both educating and promoting a process for achieving a standard while simultaneously inspecting compliance to that standard. Ensuring pharmacies have autonomy in operationalizing standards may

  13. Accelerating the paradigm shift toward inclusion of pregnant women in drug research: Ethical and regulatory considerations.

    Science.gov (United States)

    White, Amina

    2015-11-01

    Although there has been long-standing reluctance to include pregnant women as clinical trial participants, increasing recognition of profound gaps in research on the safety and efficacy of drugs often prescribed to pregnant women calls into question the practice of routinely excluding them. This article presents compelling reasons for including pregnant women in clinical research, highlights certain regulatory barriers to the inclusion of pregnant women, and proposes that professional societies with expertise in obstetrics and maternal-fetal medicine can be instrumental in hastening the paradigm shift from the systematic exclusion of pregnant women in research to a one of responsible and fair inclusion.

  14. Regulatory volume decrease in Leishmania mexicana: effect of anti-microtubule drugs

    Directory of Open Access Journals (Sweden)

    Francehuli Dagger

    2013-02-01

    Full Text Available The trypanosomatid cytoskeleton is responsible for the parasite's shape and it is modulated throughout the different stages of the parasite's life cycle. When parasites are exposed to media with reduced osmolarity, they initially swell, but subsequently undergo compensatory shrinking referred to as regulatory volume decrease (RVD. We studied the effects of anti-microtubule (Mt drugs on the proliferation of Leishmania mexicana promastigotes and their capacity to undergo RVD. All of the drugs tested exerted antiproliferative effects of varying magnitudes [ansamitocin P3 (AP3> trifluoperazine > taxol > rhizoxin > chlorpromazine]. No direct relationship was found between antiproliferative drug treatment and RVD. Similarly, Mt stability was not affected by drug treatment. Ansamitocin P3, which is effective at nanomolar concentrations, blocked amastigote-promastigote differentiation and was the only drug that impeded RVD, as measured by light dispersion. AP3 induced 2 kinetoplasts (Kt 1 nucleus cells that had numerous flagella-associated Kts throughout the cell. These results suggest that the dramatic morphological changes induced by AP3 alter the spatial organisation and directionality of the Mts that are necessary for the parasite's hypotonic stress-induced shape change, as well as its recovery.

  15. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies

    Science.gov (United States)

    Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

    2017-01-01

    Objectives To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. Design Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. Setting Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany. Main outcome measures Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions. Results Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals. Conclusions Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are

  16. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies.

    Science.gov (United States)

    Spelsberg, Angela; Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

    2017-02-07

     To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act.  Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10.  Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany.  Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions.  Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals.  Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are strictly obliged to maintain confidentiality towards the

  17. Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development.

    Science.gov (United States)

    Li, Min; Sander, Sanna; Duan, John; Rosencrance, Susan; Miksinski, Sarah Pope; Yu, Lawrence; Seo, Paul; Rege, Bhagwant

    2016-11-01

    This review presents scientific and regulatory considerations for the development of solid oral modified release (MR) drug products. It includes a rationale for patient-focused development based on Quality-by-Design (QbD) principles. Product and process understanding of MR products includes identification and risk-based evaluation of critical material attributes (CMAs), critical process parameters (CPPs), and their impact on critical quality attributes (CQAs) that affect the clinical performance. The use of various biopharmaceutics tools that link the CQAs to a predictable and reproducible clinical performance for patient benefit is emphasized. Product and process understanding lead to a more comprehensive control strategy that can maintain product quality through the shelf life and the lifecycle of the drug product. The overall goal is to develop MR products that consistently meet the clinical objectives while mitigating the risks to patients by reducing the probability and increasing the detectability of CQA failures.

  18. Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks.

    Science.gov (United States)

    Gronde, Toon van der; Uyl-de Groot, Carin A; Pieters, Toine

    2017-01-01

    Recent public outcry has highlighted the rising cost of prescription drugs worldwide, which in several disease areas outpaces other health care expenditures and results in a suboptimal global availability of essential medicines. A systematic review of Pubmed, the Financial Times, the New York Times, the Wall Street Journal and the Guardian was performed to identify articles related to the pricing of medicines. Changes in drug life cycles have dramatically affected patent medicine markets, which have long been considered a self-evident and self-sustainable source of income for highly profitable drug companies. Market failure in combination with high merger and acquisition activity in the sector have allowed price increases for even off-patent drugs. With market interventions and the introduction of QALY measures in health care, governments have tried to influence drug prices, but often encounter unintended consequences. Patent reform legislation, reference pricing, outcome-based pricing and incentivizing physicians and pharmacists to prescribe low-cost drugs are among the most promising short-term policy options. Due to the lack of systematic research on the effectiveness of policy measures, an increasing number of ad hoc decisions have been made with counterproductive effects on the availability of essential drugs. Future challenges demand new policies, for which recommendations are offered. A fertile ground for high-priced drugs has been created by changes in drug life-cycle dynamics, the unintended effects of patent legislation, government policy measures and orphan drug programs. There is an urgent need for regulatory reform to curtail prices and safeguard equitable access to innovative medicines.

  19. Statistical and regulatory considerations in assessments of interchangeability of biological drug products.

    Science.gov (United States)

    Tóthfalusi, Lászlo; Endrényi, László; Chow, Shein-Chung

    2014-05-01

    When the patent of a brand-name, marketed drug expires, new, generic products are usually offered. Small-molecule generic and originator drug products are expected to be chemically identical. Their pharmaceutical similarity can be typically assessed by simple regulatory criteria such as the expectation that the 90% confidence interval for the ratio of geometric means of some pharmacokinetic parameters be between 0.80 and 1.25. When such criteria are satisfied, the drug products are generally considered to exhibit therapeutic equivalence. They are then usually interchanged freely within individual patients. Biological drugs are complex proteins, for instance, because of their large size, intricate structure, sensitivity to environmental conditions, difficult manufacturing procedures, and the possibility of immunogenicity. Generic and brand-name biologic products can be expected to show only similarity but not identity in their various features and clinical effects. Consequently, the determination of biosimilarity is also a complicated process which involves assessment of the totality of the evidence for the close similarity of the two products. Moreover, even when biosimilarity has been established, it may not be assumed that the two biosimilar products can be automatically substituted by pharmacists. This generally requires additional, careful considerations. Without declaring interchangeability, a new product could be prescribed, i.e. it is prescribable. However, two products can be automatically substituted only if they are interchangeable. Interchangeability is a statistical term and it means that products can be used in any order in the same patient without considering the treatment history. The concepts of interchangeability and prescribability have been widely discussed in the past but only in relation to small molecule generics. In this paper we apply these concepts to biosimilars and we discuss: definitions of prescribability and interchangeability and

  20. Influence of regulatory measures on the rate of spontaneous adverse drug reaction reporting in Italy.

    Science.gov (United States)

    Motola, Domenico; Vargiu, Antonio; Leone, Roberto; Conforti, Anita; Moretti, Ugo; Vaccheri, Alberto; Velo, Giampaolo; Montanaro, Nicola

    2008-01-01

    The reporting of adverse drug reactions (ADRs) is the mainstay of post-marketing surveillance systems. Under-reporting and selective reporting are considered the main limitations of a spontaneous reporting-based pharmacovigilance system. However, excessive reporting induced by external events may also impair signal detection by increasing the noise level. The aim of this study was to examine the influence of regulatory measures and other external factors on the rate of ADR reporting in Italy, focusing on four situations occurring in the last 10 years: ACE inhibitor-induced cough; HMG-CoA reductase inhibitors ('statins') and rhabdomyolysis; nimesulide and hepatic toxicity; and cyclo-oxygenase (COX)-2 selective inhibitors ('coxibs') and increase in cardiovascular risk. The study was based on data from spontaneous reporting in six Italian regions collected from January 1995 to December 2005. We analysed a 10-year period as a reasonable time interval around the four situations of interest, highlighting the influence of regulatory measures on the rate of ADR reporting (number of reports per million inhabitants). Chi-squared tests were used to assess the statistical significance of any changes in ADR reporting. Drug sales data were also studied to examine possible changes in drug use. Sales data were expressed as daily defined dose per 1000 inhabitants per day. ACE inhibitors: a 5-fold increase in the reporting rate of ACE inhibitor-induced cough was observed in 1998 and 1999 following a restriction on reimbursement for angiotensin receptor blockers introduced in 1998 and removed at the end of 1999. Statins: after the withdrawal of cerivastatin in 2001, the ADR reporting rate increased more than 4-fold, with musculoskeletal ADRs representing about 60% of all the ADRs reported in that year, and progressively decreased in the following years. Nimesulide: an increase in hepatic ADR reporting was observed after withdrawal of the drug from the Finnish and Spanish markets in

  1. [Amiodaron neuropathy: clinical and pathological study of a new drug induced lipidosis (author's transl)].

    Science.gov (United States)

    Dudognon, P; Hauw, J J; de Baecque, C; Derrida, J P; Escourolle, R; Nick, E J

    1979-01-01

    The authors report a case of amiodaron-induced neuropathy in a seventy one years old man. First signs appeared seventeen months after the treatment was started with 400 mg/day for one year and continued with 200 mg/day. Examination on the 29th month disclosed a severe sensory and motor deficit of the limbs with distal predominancy. Motor nerve conduction velocity was strongly impaired without modification of distal latencies. Fundi were normal. The patient improved quickly after drug withdrawal. The authors review the rare similar cases reported in the literature and attempt to describe the clinical caracteristics of amiodaron neuropathy. Qualitative and quantitative light and electron microscopical studies of nerve, muscle and skin biopsies, including teased fibers preparations were performed and they disclosed a marked reduction of the number of myelinated fibers. Wallerian degeneration predominated (31 p. 100) other segmental demyalination (25 p. 100). Numerous polymorphous lipid-laden lysosomes were present in Schwann cells, fibrocytes, pericytes, endothelial and muscle cells. These previously undescribed morphological findings are similar to those present in perhexiline maleate intoxications. We believe amiodaron neuropathy is a new neuropathy with drug-induced lipidosis.

  2. Regulatory approval of cancer risk-reducing (chemopreventive) drugs: moving what we have learned into the clinic.

    Science.gov (United States)

    Meyskens, Frank L; Curt, Gregory A; Brenner, Dean E; Gordon, Gary; Herberman, Ronald B; Finn, Olivera; Kelloff, Gary J; Khleif, Samir N; Sigman, Caroline C; Szabo, Eva

    2011-03-01

    This article endeavors to clarify the current requirements and status of regulatory approval for chemoprevention (risk reduction) drugs and discusses possible improvements to the regulatory pathway for chemoprevention. Covering a wide range of topics in as much depth as space allows, this report is written in a style to facilitate the understanding of nonscientists and to serve as a framework for informing the directions of experts engaged more deeply with this issue. Key topics we cover here are as follows: a history of definitive cancer chemoprevention trials and their influence on the evolution of regulatory assessments; a brief review of the long-standing success of pharmacologic risk reduction of cardiovascular diseases and its relevance to approval for cancer risk reduction drugs; the use and limitations of biomarkers for developing and the approval of cancer risk reduction drugs; the identification of individuals at a high(er) risk for cancer and who are appropriate candidates for risk reduction drugs; business models that should incentivize pharmaceutical industry investment in cancer risk reduction; a summary of scientific and institutional barriers to development of cancer risk reduction drugs; and a summary of major recommendations that should help facilitate the pathway to regulatory approval for pharmacologic cancer risk reduction drugs.

  3. Impact of regulatory measures on antipsychotics drug consumption in Castilla y León, Spain.

    Science.gov (United States)

    Martín Arias, L H; Treceño Lobato, C; Pérez García, S; García Ortega, P; Sáinz Gil, M; Sanz Fadrique, R; Carvajal García-Pando, A

    2016-12-01

    Antipsychotics are currently used to treat different diseases; even some off-labelled conditions are treated with this medication. Consumption and cost of antipsychotic drugs sharply increased in Spain after second-generation drugs were marketed; several regulatory measures were adopted to curb this trend. The aim of this study was to examine the impact of these measures upon the use and cost of antipsychotics. Study of drug use (SDU) from 1995 to 2012. Consumption and cost data were obtained from the CONCYLIA database; this database contains the retail community pharmacies sales of medicinal products reimbursed by the National Health System in Castilla y León (Spain). Data are presented as defined daily doses per 1000 inhabitants per day (DID) and day treatment cost (DTC). First-generation antipsychotics prescriptions gradually decreased from 3.0 to 1.8 DID; meanwhile, prescriptions for second-generation antipsychotics considerably increased from 0.3 to 9.9 DID. The use of risperidone dropped after the marketing of its structural derivative paliperidone with a similar efficacy but with a substantially higher cost per day. In 2011 and thereafter, patients in Spain began to pay a part of the medications cost, but this did not decrease antipsychotics consumption. Global cost of antipsychotics only began to fall after measures were adopted to lower the price of medicines because of the economic collapse in Spain after May 2010. Several health policy measures have tried to reduce antipsychotics consumption in Spain, special ways of dispensing, marketing of generic drugs and special economic measures for patients. These measures eventually failed to avoid the increase in antipsychotics use. The cost only dropped when lowering prescription drug prices took place. Copyright © 2016 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

  4. Analytical Challenges and Regulatory Requirements for Nasal Drug Products in Europe and the U.S.

    Directory of Open Access Journals (Sweden)

    Sabrina Trows

    2014-04-01

    Full Text Available Nasal drug delivery can be assessed by a variety of means and regulatory agencies, e.g., the Food and Drug Administration (FDA and the European Medicines Agency (EMA have published a set of guidelines and regulations proposing in vitro test methods for the characterization of nasal drug products. This article gives a summary of the FDA and EMA requirements regarding the determination of droplet size distribution (DSD, plume geometry, spray pattern and shot weights of solution nasal sprays and discusses the analytical challenges that can occur when performing these measurements. In order to support findings from the literature, studies were performed using a standard nasal spray pump and aqueous model formulations. The aim was to identify possible method-, device- and formulation-dependent influencing factors. The literature review, as well as the results from the studies show that DSD, plume geometry and spray pattern are influenced by, e.g., the viscosity of the solution, the design of the device and the actuation parameters, particularly the stroke length, actuation velocity and actuation force. The dominant factor influencing shot weights, however, is the adjustment of the actuation parameters, especially stroke length and actuation velocity. Consequently, for routine measurements assuring, e.g., the quality of a solution nasal spray or, for in vitro bioequivalence studies, the critical parameters, have to be identified and considered in method development in order to obtain reproducible and reliable results.

  5. FDA relations during drug development

    OpenAIRE

    Mitchel, Jules T.

    2000-01-01

    Working closely and cooperatively with regulatory authorities during drug development is vital to successful drug development programs. In the United States, the drug development team includes not only members of the key disciplines of drug discovery, clinical research, regulatory affairs, marketing, chemistry, toxicology, and legal aspects, but also the Food and Drug Administration (FDA). New regulations encourage meetings at the pre-investigational new drug (pre-IND), end-of-phase-2, and pr...

  6. Drug policy and global regulatory capitalism: the case of new psychoactive substances (NPS).

    Science.gov (United States)

    Seddon, Toby

    2014-09-01

    The recent emergence of vibrant markets in 'new psychoactive substances' or 'legal highs' has posed significant new challenges for drug policy. These partly concern what to do about them but the speed and complexity of change has also raised difficulties for how policy responses should be developed. Existing drug policy systems appear too slow and cumbersome to keep up with the pace of change, remaining locked in large part within 'old' ways of thinking that centre almost exclusively around the deployment (or not) of the criminal law and its related enforcement apparatus. In this paper, it is argued that we need to rethink the problem through the lens of regulation, in order to learn lessons from other sectors where more agile responses to changing markets and business innovation have often proved possible. By examining examples drawn from these other areas, an alternative policy-making framework can be developed, involving a more flexible mix of state regulation, civil society action and private law mechanisms. This new approach is founded on a recognition of the networked and polycentric character of effective market governance in an era of global regulatory capitalism. Copyright © 2014 Elsevier B.V. All rights reserved.

  7. Regulatory Experience with In Vivo In Vitro Correlations (IVIVC) in New Drug Applications.

    Science.gov (United States)

    Suarez-Sharp, Sandra; Li, Min; Duan, John; Shah, Heta; Seo, Paul

    2016-11-01

    In the past two decades, in vitro in vivo correlation (IVIVC) has been considered an important tool for supporting biowaivers, setting dissolution acceptance criteria, and more recently in the Quality by Design (QbD) framework promoting the establishment of clinically meaningful drug product specifications using dissolution as the endpoint. Based on our review experience at the FDA, for the purposes of this article, we analyzed the current state of regulatory submissions containing IVIVC approaches and discussed the successes and failures from the perspectives of study design to methodology. In the past decade, the overall acceptance rate of the IVIVC submissions is about 40%. Moreover, the number of IVIVC studies seen in the submissions per year is not increasing. Establishing clinically meaningful drug product specifications through the linkages between the identified critical quality attributes and in vivo performance is key for developing a quality drug product. To achieve this goal, there is an imminent need for addressing the issues behind a low success rate in IVIVC development. The results from the current analysis revealed that special considerations should be taken in areas such as (1) selection of appropriate number/kind of formulations for IVIVC development/validation, (2) construction of exploratory plots to guide model building and selection, (3) investigation of the reasons of inconclusive predictability, (4) improvement on the quality and richness of the data, and (5) avoidance of over parameterization. The development and incorporation of biopredictive dissolution methods and the use of non-conventional approaches, including mechanistic/physiologically based approaches, should be explored to increase the likelihood of IVIVC success.

  8. Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products.

    Science.gov (United States)

    Lucas-Samuel, Sophie; Ferry, Nicolas; Trouvin, Jean-Hugues

    2015-01-01

    Advanced therapy medicinal products, a new class of products with promising therapeutic effects, have been classified as medicinal products and as such should be developed according to a well-structured development plan, to establish their quality, safety and efficacy profile and conclude, at the time of the marketing authorisation evaluation, on a positive risk/benefit balance for patients. An important part of this development plan is achieved through clinical trials, which have also to be approved according to a well-established regulatory process, prior any initiation. This chapter is dedicated to describe the regulatory pathway to be followed in France, before initiating any clinical trial with those investigational advanced therapy medicinal products. In France, to get the final authorisation to initiate a clinical trial, the legislation imposes to run in parallel two independent but complementary authorisation procedures. The first procedure is aimed at assessing the ethical aspect of the biomedical research, while the second has to review the safety and regulatory aspects. A third procedure has to be envisaged where in case the investigational product consists or contains a genetically modified organism. The French system herein described is in line with the EU regulation on clinical trial and follows the respective deadlines for granting the final approval. The complexity of the procedure is in fact more due to the complexity of the products and protocols to be assessed than to the procedure itself which is now very close to the well-known procedure applied routinely for more conventional chemical or biological candidate medicinal products.

  9. The safety, efficacy and regulatory triangle in drug development: Impact for animal models and the use of animals.

    Science.gov (United States)

    van Meer, Peter J K; Graham, Melanie L; Schuurman, Henk-Jan

    2015-07-15

    Nonclinical studies in animals are conducted to demonstrate proof-of-concept, mechanism of action and safety of new drugs. For a large part, in particular safety assessment, studies are done in compliance with international regulatory guidance. However, animal models supporting the initiation of clinical trials have their limitations, related to uncertainty regarding the predictive value for a clinical condition. The 3Rs principles (refinement, reduction and replacement) are better applied nowadays, with a more comprehensive application with respect to the original definition. This regards also regulatory guidance, so that opportunities exist to revise or reduce regulatory guidance with the perspective that the optimal balance between scientifically relevant data and animal wellbeing or a reduction in animal use can be achieved. In this manuscript we review the connections in the triangle between nonclinical efficacy/safety studies and regulatory aspects, with focus on in vivo testing of drugs. These connections differ for different drugs (chemistry-based low molecular weight compounds, recombinant proteins, cell therapy or gene therapy products). Regarding animal models and their translational value we focus on regulatory aspects and indications where scientific outcomes warrant changes, reduction or replacement, like for, e.g., biosimilar evaluation and safety testing of monoclonal antibodies. On the other hand, we present applications where translational value has been clearly demonstrated, e.g., immunosuppressives in transplantation. Especially for drugs of more recent date like recombinant proteins, cell therapy products and gene therapy products, a regulatory approach that allows the possibility to conduct combined efficacy/safety testing in validated animal models should strengthen scientific outcomes and improve translational value, while reducing the numbers of animals necessary. Copyright © 2015 Elsevier B.V. All rights reserved.

  10. Examining characteristics, knowledge and regulatory practices of specialized drug shops in Sub-Saharan Africa: a systematic review of the literature

    Directory of Open Access Journals (Sweden)

    Wafula Francis N

    2012-07-01

    Full Text Available Abstract Background Specialized drug shops such as pharmacies and drug shops are increasingly becoming important sources of treatment. However, knowledge on their regulatory performance is scarce. We set out to systematically review literature on the characteristics, knowledge and practices of specialized drug shops in Sub-Saharan Africa. Methods We searched PubMed, EMBASE, WEB of Science, CAB Abstracts, PsycINFO and websites for organizations that support medicine policies and usage. We also conducted open searches using Google Scholar, and searched manually through references of retrieved articles. Our search included studies of all designs that described characteristics, knowledge and practices of specialized drug shops. Information was abstracted on authors, publication year, country and location, study design, sample size, outcomes investigated, and primary findings using a uniform checklist. Finally, we conducted a structured narrative synthesis of the main findings. Results We obtained 61 studies, mostly from Eastern Africa, majority of which were conducted between 2006 and 2011. Outcome measures were heterogeneous and included knowledge, characteristics, and dispensing and regulatory practices. Shop location and client demand were found to strongly influence dispensing practices. Whereas shops located in urban and affluent areas were more likely to provide correct treatments, those in rural areas provided credit facilities more readily. However, the latter also charged higher prices for medicines. A vast majority of shops simply sold whatever medicines clients requested, with little history taking and counseling. Most shops also stocked popular medicines at the expense of policy recommended treatments. Treatment policies were poorly communicated overall, which partly explained why staff had poor knowledge on key aspects of treatment such as medicine dosage and side effects. Overall, very little is known on the link between regulatory

  11. Clinical trial designs to obtain marketing authorization of drugs for haematological malignancy in Japan, the EU and the US.

    Science.gov (United States)

    Nagai, Sumimasa; Ozawa, Keiya

    2016-07-01

    Differences in regulatory actions between Japan, the European Union (EU) and the United States (US) regarding the approval date and primary endpoints of pivotal trials have never been analysed comprehensively. This study aimed to examine such differences in haematological malignancy indications not only in applications for new molecular entity agents but also in supplemental applications for additional indications. A total of 101 haematological malignancy indications were examined for 58 drugs. Only 30 indications were approved by the regulatory agencies of all three regions with 25, 9 and 67 indications being first approved in Japan, the EU and the US, respectively. Regarding the 18 indications approved only in the US, 13 were approved based on results of single-arm trials. The approval of all nine indications approved first in the EU was based on results of comparative trials. The primary endpoints were different between the EU and the US in 4 of 49 indications approved by both regulatory agencies, all of which were approved earlier in the US than in the EU. This analysis shows that the US Food and Drug Administration has taken the most active attitude to acceptance of surrogate endpoints in single-arm trials. Therefore, not only shorter review time but also this attitude may lead to earlier approval in US. © 2016 John Wiley & Sons Ltd.

  12. 75 FR 20429 - Amended Authorizations of Emergency Use of Certain Antiviral Drugs Zanamivir and Oseltamivir...

    Science.gov (United States)

    2010-04-19

    ... time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example... Committee on Immunization Practices. Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might...

  13. Exploratory safety pharmacology: a new safety paradigm to de-risk drug candidates prior to selection for regulatory science investigations.

    Science.gov (United States)

    Cavero, Icilio

    2009-11-01

    The primary objective of Safety Pharmacology is to ensure the safety of medicines on physiological functions in order to protect humans against adverse drug reactions. Safety Pharmacology became a major non-clinical discipline in 2000 when the International Conference on Harmonization approved the S7A guideline. This regulatory document requires pharmaceutical companies to undertake Safety Pharmacology assessment under Good Laboratory Practice (GLP) in order to guarantee the absence of unmanageable risks on vital organ function for compounds to be tested on humans. These regulatory studies often reveal liabilities impacting on the smooth transition of drug candidates from the discovery phase into the clinical arena. However, if these safety issues were uncovered prior to regulatory science assessment, the chemistry of poorly safe molecules could be modified during the lead optimisation phase for preventing later occurring attrition accidents. This article proposes the establishment of a spin-off specialty of Regulatory Safety Pharmacology, for which the name 'Exploratory Safety Pharmacology' is proposed. The objective of this discipline would be to conduct early safety investigations on potential drug candidates by applying, outside the constraints of GLP, in silico, in vitro, ex vivo and in vivo platforms translating clinical liabilities into simple, fast and cost-effective screening assays. This approach should result in early hazard detection with rapid turnaround of the data, enabling medicinal chemists to mitigate the safety liabilities of new compounds in an iterative manner. Hence, the ultimate aim of Exploratory Safety Pharmacology activities is to transform Regulatory Safety Pharmacology investigations into risk-known exercises.

  14. Advancing regulatory science to bring novel medical devices for use in emergency care to market: the role of the Food and Drug Administration.

    Science.gov (United States)

    Scully, Christopher G; Forrest, Shawn; Galeotti, Loriano; Schwartz, Suzanne B; Strauss, David G

    2015-04-01

    The Food and Drug Administration (FDA) performs regulatory science to provide science-based medical product regulatory decisions. This article describes the types of scientific research the FDA's Center for Devices and Radiological Health performs and highlights specific projects related to medical devices for emergency medicine. In addition, this article discusses how results from regulatory science are used by the FDA to support the regulatory process as well as how the results are communicated to the public. Regulatory science supports the FDA's mission to assure safe, effective, and high-quality medical products are available to patients.

  15. Sphaeropsidin A shows promising activity against drug-resistant cancer cells by targeting regulatory volume increase

    Science.gov (United States)

    Mathieu, Véronique; Chantôme, Aurélie; Lefranc, Florence; Cimmino, Alessio; Miklos, Walter; Paulitschke, Verena; Mohr, Thomas; Maddau, Lucia; Kornienko, Alexander; Berger, Walter; Vandier, Christophe; Evidente, Antonio; Delpire, Eric; Kiss, Robert

    2016-01-01

    Despite the recent advances in the treatment of tumors with intrinsic chemotherapy resistance, such as melanoma and renal cancers, their prognosis remains poor and new chemical agents with promising activity against these cancers are urgently needed. Sphaeropsidin A, a fungal metabolite whose anticancer potential had previously received little attention, was isolated from Diplodia cupressi and found to display specific anticancer activity in vitro against melanoma and kidney cancer subpanels in the National Cancer Institute (NCI) 60-cell line screen. The NCI data revealed a mean LC50 of ca. 10 μM and a cellular sensitivity profile that did not match that of any other agent in the 765,000 compound database. Subsequent mechanistic studies in melanoma and other multidrug-resistant in vitro cancer models showed that sphaeropsidin A can overcome apoptosis as well as multidrug resistance by inducing a marked and rapid cellular shrinkage related to the loss of intracellular Cl− and the decreased HCO3− concentration in the culture supernatant. These changes in ion homeostasis and the absence of effects on the plasma membrane potential were attributed to the sphaeropsidin A-induced impairment of regulatory volume increase (RVI). Preliminary results also indicate that depending on the type of cancer, the sphaeropsidin A effects on RVI could be related to Na–K–2Cl electroneutral cotransporter or Cl−/HCO3− anion exchanger(s) targeting. This study underscores the modulation of ion-transporter activity as a promising therapeutic strategy to combat drug-resistant cancers and identifies the fungal metabolite, sphaeropsidin A, as a lead to develop anticancer agents targeting RVI in cancer cells. PMID:25868554

  16. Drug product registration and marketing authorization procedures in EU-A perspective

    OpenAIRE

    Swati Karande; Krishnamurthy Bhat; Manthan Janodia; PC, Jagadish; Ashish Kekare; Udupa, N

    2013-01-01

    ABSTRACTThere are 27 European Union (EU) member states, 3 European Economic Area (EEA) andEuropean Free Trade Association (EFTA) states. For a company willing to market the medicinalproduct in to the EEA, marketing authorization (MA) for the respective product mustbe issued by competent authority of member state or authorization granted according toRegulation (EC) No. 726/2004 for entire community. Europe constitutes large population andEuropean government is alert regarding safety of the pub...

  17. Examination of the regulatory frameworks applicable to biologic drugs (including stem cells and their progeny) in Europe, the U.S., and Australia: part I--a method of manual documentary analysis.

    Science.gov (United States)

    Ilic, Nina; Savic, Snezana; Siegel, Evan; Atkinson, Kerry; Tasic, Ljiljana

    2012-12-01

    Recent development of a wide range of regulatory standards applicable to production and use of tissues, cells, and other biologics (or biologicals), as advanced therapies, indicates considerable interest in the regulation of these products. The objective of this study was to analyze and compare high-tier documents within the Australian, European, and U.S. biologic drug regulatory environments using qualitative methodology. Cohort 1 of the selected 18 high-tier regulatory documents from the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Therapeutic Goods Administration (TGA) regulatory frameworks were subject to a manual documentary analysis. These documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Manual analysis included a terminology search. The occurrence, frequency, and interchangeable use of different terms and phrases were recorded in the manual documentary analysis. Despite obvious differences, manual documentary analysis revealed certain consistency in use of terminology across analyzed frameworks. Phrase search frequencies have shown less uniformity than the search of terms. Overall, the EMA framework's documents referred to "medicinal products" and "marketing authorization(s)," the FDA documents discussed "drug(s)" or "biologic(s)," and the TGA documents referred to "biological(s)." Although high-tier documents often use different terminology they share concepts and themes. Documents originating from the same source have more conjunction in their terminology although they belong to different frameworks (i.e., Good Clinical Practice requirements based on the Declaration of Helsinki, 1964). Automated (software-based) documentary analysis should be obtained for the conceptual and relational analysis.

  18. Clinical validation protocols for noninvasive blood pressure monitors and their recognition by regulatory authorities and professional organizations: rationale and considerations for a single unified protocol or standard.

    Science.gov (United States)

    Ng, Kim-Gau

    2013-10-01

    Standardized protocols for validating the clinical accuracy of noninvasive blood pressure (NIBP) monitors have been available since 1987. Some of them were developed by standards bodies and others by professional organizations. They have been well-tested through use and progressively improved through multiple revisions; however, many methodological differences exist between them. In addition, for the purpose of regulatory approval or marketing clearance, some protocols are recognized in some countries but not in others; thus, manufacturers have to validate their NIBP monitors to more than one protocol in order to market them worldwide. The use of different protocols not only makes it difficult to compare one device with another but also complicates the validation, regulatory approval, marketing, and public acceptance of NIBP monitors, creating undue burden on manufacturers and unnecessary confusion among users. There is a need for protocol developers, standards bodies, and regulatory authorities to work together to develop and agree on a single unified protocol or standard, one that builds on the strengths of the various protocols that have been developed so far. It is apparent that there is already a trend toward convergence of the various protocols into two protocols, namely, the ISO 81060-2:2009 standard and the 2010 European Society of Hypertension International Protocol. With further reconciliation and consensus, it should be possible to integrate the best features of the ISO, European Society of Hypertension, and other protocols, along with further improvements, into a single unified protocol or standard.

  19. Reconciling Estimates of the Value to Firms of Reduced Regulatory Delay in the Marketing of Their New Drugs.

    Science.gov (United States)

    Wilmoth, Daniel R

    2015-12-01

    The prescription drug user fee program provides additional resources to the U.S. Food and Drug Administration at the expense of regulated firms. Those resources accelerate the review of new drugs. Faster approvals allow firms to realize profits sooner, and the program is supported politically by industry. However, published estimates of the value to firms of reduced regulatory delay vary dramatically. It is shown here that this variation is driven largely by differences in methods that correspond to differences in implicit assumptions about the effects of reduced delay. Theoretical modeling is used to derive an equation describing the relationship between estimates generated using different methods. The method likely to yield the most accurate results is identified. A reconciliation of published estimates yields a value to a firm for a one-year reduction in regulatory delay at the time of approval of about $60 million for a typical drug. Published 2015. This article is a U.S. Government work and is in the public domain in the U.S.A.

  20. DrugCentral: online drug compendium.

    Science.gov (United States)

    Ursu, Oleg; Holmes, Jayme; Knockel, Jeffrey; Bologa, Cristian G; Yang, Jeremy J; Mathias, Stephen L; Nelson, Stuart J; Oprea, Tudor I

    2017-01-04

    DrugCentral (http://drugcentral.org) is an open-access online drug compendium. DrugCentral integrates structure, bioactivity, regulatory, pharmacologic actions and indications for active pharmaceutical ingredients approved by FDA and other regulatory agencies. Monitoring of regulatory agencies for new drugs approvals ensures the resource is up-to-date. DrugCentral integrates content for active ingredients with pharmaceutical formulations, indexing drugs and drug label annotations, complementing similar resources available online. Its complementarity with other online resources is facilitated by cross referencing to external resources. At the molecular level, DrugCentral bridges drug-target interactions with pharmacological action and indications. The integration with FDA drug labels enables text mining applications for drug adverse events and clinical trial information. Chemical structure overlap between DrugCentral and five online drug resources, and the overlap between DrugCentral FDA-approved drugs and their presence in four different chemical collections, are discussed. DrugCentral can be accessed via the web application or downloaded in relational database format. © The Author(s) 2016. Published by Oxford University Press on behalf of Nucleic Acids Research.

  1. [Inhibition of menstrual uterine motility with four beta-adrenergic drugs (author's transl)].

    Science.gov (United States)

    Cifuentes, R; Cobo, E

    1981-01-01

    Effects of the sublingual administration of four beta-adrenoceptor drugs on the uterine motility in 40 normal menstruating women were studied. The drugs and total doses tested were: orciprenaline (40 mg), Partusisten (10 mg), salbutamol (8 mg) and isoxsuprine (40 mg). The uterine and antidiuretic activities were studied before and after administration of each one. All those drugs employed reduced greatly the uterine contractions in all the patients. The cardiovascular side-effects were minimal and well tolerated. It suggested that the adrenergic system has an important role in the control of uterine motility during human menstruation.

  2. Unproven stem cell-based interventions & physicians' professional obligations; a qualitative study with medical regulatory authorities in Canada.

    Science.gov (United States)

    Zarzeczny, Amy; Clark, Marianne

    2014-10-14

    The pursuit of unproven stem cell-based interventions ("stem cell tourism") is an emerging issue that raises various concerns. Physicians play different roles in this market, many of which engage their legal, ethical and professional obligations. In Canada, physicians are members of a self-regulated profession and their professional regulatory bodies are responsible for regulating the practice of medicine and protecting the public interest. They also provide policy guidance to their members and discipline members for unprofessional conduct. We conducted semi-structured telephone interviews with representatives from six different provincial Colleges of Physicians and Surgeons in Canada to discuss their experiences and perspectives regarding stem cell tourism. Our focus was on exploring how different types of physician involvement in this market would be viewed by physicians' professional regulatory bodies in Canada. When considering physicians' professional obligations, participants drew analogies between stem cell tourism and other areas of medical tourism as well as with some aspects of complementary alternative medicine where existing policies, codes of ethics and regulations provide some guidance. Canadian physicians are required to act in the best interests of their patients, respect patient autonomy, avoid conflicts of interest and pursue evidence-based practice in accordance with accepted standards of care. Physicians who provide unproven treatments falling outside the standard of care, not in the context of an approved research protocol, could be subject to professional discipline. Other types of problematic conduct include referrals involving financial conflict of interest and failure to provide urgent medically necessary care. Areas of ambiguity include physicians' obligations when asked for information and advice about seeking unproven medical treatments, in terms of providing non-urgent follow-up care, and when asked to support efforts to go abroad by

  3. Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India.

    Science.gov (United States)

    Lee, Sau L; Saluja, Bhawana; García-Arieta, Alfredo; Santos, Gustavo Mendes Lima; Li, Ying; Lu, Sarah; Hou, Shuguang; Rebello, Juliet; Vaidya, Abhijit; Gogtay, Jaideep; Purandare, Shrinivas; Lyapustina, Svetlana

    2015-09-01

    This article describes regulatory approaches for approval of "generic" orally inhaled drug products (OIDPs) in the United States, European Union, Brazil, China and India. While registration of a generic OIDP in any given market may require some documentation of the formulation and device similarity to the "original" product as well as comparative testing of in vitro characteristics and in vivo performance, the specific documentation approaches, tests and acceptance criteria vary by the country. This divergence is due to several factors, including unique cultural, historical, legal and economic circumstances of each region; the diverse healthcare and regulatory systems; the different definitions of key terms such as "generic" and "reference" drug; the acknowledged absence of in vitro in vivo correlations for OIDPs; and the scientific and statistical issues related to OIDP testing (such as how best to account for the batch-to-batch variability of the Reference product, whether to use average bioequivalence or population bioequivalence in the statistical analysis of results, whether to use healthy volunteers or patients for pharmacokinetic studies, and which pharmacodynamic or clinical end-points should be used). As a result of this discrepancy, there are ample opportunities for the regulatory and scientific communities around the world to collaborate in developing more consistent, better aligned, science-based approaches. Moving in that direction will require both further research and further open discussion of the pros and cons of various approaches.

  4. Impact of Safety-Related Regulatory Action on Drug Use in Ambulatory Care in the Netherlands

    NARCIS (Netherlands)

    Piening, S.; Reber, K. C.; Wieringa, J. E.; Straus, S. M. J. M.; de Graeff, P. A.; Haaijer-Ruskamp, F. M.; Mol, P. G. M.

    2012-01-01

    The effect of Direct Healthcare Professional Communications (DHPCs) informing health-care providers of serious drug safety issues has been questioned. The aim of this study was to evaluate the impact of DHPCs on drug use. Nationwide dispensing data for the period 2000-2008 for new users of 46 drugs

  5. Impact of Safety-Related Regulatory Action on Drug Use in Ambulatory Care in the Netherlands

    NARCIS (Netherlands)

    Piening, S.; Reber, K. C.; Wieringa, J. E.; Straus, S. M. J. M.; de Graeff, P. A.; Haaijer-Ruskamp, F. M.; Mol, P. G. M.

    The effect of Direct Healthcare Professional Communications (DHPCs) informing health-care providers of serious drug safety issues has been questioned. The aim of this study was to evaluate the impact of DHPCs on drug use. Nationwide dispensing data for the period 2000-2008 for new users of 46 drugs

  6. [Effects of an antiinflammatory drug (diclofenac) in primary chronic glomerulo-nephritis (author's transl)].

    Science.gov (United States)

    Lagrue, G; Hirbec, G

    Chronic Glomerulo-Nephritis (GN) are among nephrologic diseases, frequent and severe. In most of them immunological process are involved. Non steroïdal antiinflammatory drugs are able to reduce proteinuria, mainly in Membrano-Proliferative GN and IgA Mesengial GN. A protracted administration is necessary for proteinuria reappeared when treatment is interrupted. With long term administration renal prognosis is improved and severe renal insufficiency delayed. Among active antiinflammatory drugs (indometacine, ketoprofen, diclofenac, flurbiprofen, etc.) diclofenac is one of the best tolerated.

  7. A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development.

    Science.gov (United States)

    Robinson, Sally; Delongeas, Jean-Luc; Donald, Elizabeth; Dreher, David; Festag, Matthias; Kervyn, Sophie; Lampo, Ann; Nahas, Kamil; Nogues, Vicente; Ockert, Deborah; Quinn, Kirsty; Old, Sally; Pickersgill, Nigel; Somers, Kev; Stark, Claudia; Stei, Peter; Waterson, Lynne; Chapman, Kathryn

    2008-04-01

    Regulatory guidelines indicate acute toxicity studies in animals are considered necessary for pharmaceuticals intended for human use. This is the only study type where lethality is mentioned as an endpoint. The studies are carried out, usually in rodents, to support marketing of new drugs and to identify the minimum lethal dose. A European initiative including 18 companies has undertaken an evidence-based review of acute toxicity studies and assessed the value of the data generated. Preclinical and clinical information was shared on 74 compounds. The analysis indicated acute toxicity data was not used to (i) terminate drugs from development (ii) support dose selection for repeat dose studies in animals or (iii) to set doses in the first clinical trials in humans. The conclusion of the working group is that acute toxicity studies are not needed prior to first clinical trials in humans. Instead, information can be obtained from other studies, which are performed at more relevant doses for humans and are already an integral part of drug development. The conclusions have been discussed and agreed with representatives of regulatory bodies from the US, Japan and Europe.

  8. 75 FR 4982 - Redelegation of Functions; Delegation of Authority to Drug Enforcement Administration Official

    Science.gov (United States)

    2010-02-01

    ... Administration (DEA), Department of Justice, is amending the appendix to the Justice Department regulations to... Enforcement Administration Official AGENCY: Drug Enforcement Administration (DEA), Department of Justice... Substances Act and subsequently delegated to the Administrator of DEA. DATES: Effective Dates: This Final...

  9. 42 CFR 2.1 - Statutory authority for confidentiality of drug abuse patient records.

    Science.gov (United States)

    2010-10-01

    ... HUMAN SERVICES GENERAL PROVISIONS CONFIDENTIALITY OF ALCOHOL AND DRUG ABUSE PATIENT RECORDS Introduction... this section. (b) Purposes and circumstances of disclosure affecting consenting patient and patient... the injury to the patient, to the physician-patient relationship, and to the treatment services....

  10. Revival of the regulatory T cell: new targets for drug development.

    NARCIS (Netherlands)

    Sutmuller, R.P.M.; Offringa, R.; Melief, C.J.

    2004-01-01

    Compelling new evidence supports the idea that regulatory T cells play a major role in our immune system. Several subsets of these regulators have been identified recently. Differences in the phenotypical and functional characteristics of these subsets have immunological implications. From our growi

  11. NEW ANTIARRHYTHMIC DRUG FOR THE TREATMENT OF ATRIAL FIBRILLATION. STUDY DATA, CLINICAL GUIDELINES, REGULATORY AGENCY RECOMMENDATIONS

    Directory of Open Access Journals (Sweden)

    S. Yu. Martsevich

    2011-01-01

    Full Text Available The main objectives and strategies for treatment of atrial fibrillation (AF, one of the most common cardiac arrhythmia, are seen. A combination of strategies for heart rate control in patients with atrial fibrillation receiving rhythm-controling therapy is preferred at present, according to current guidelines. Amiodarone, one of the most effective anti-arrhythmic drugs with an extensive evidence base, remains the drug of reserve because of serious side effects. A new drug, dronedarone, has electrophysiological properties attributable to all four classes of antiarrhythmic drugs. According to meta-analysis of randomized clinical trials dronedarone is inferior to amiodarone in prevention of AF recurrences, but it is superior to amiodaron in safety. However , in 2011 dronedarone was included in the Food and Drug Administration (FDA list of drugs that require further analysis in connection with appearance of the new information about its safety.

  12. Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes.

    Science.gov (United States)

    Kesselheim, Aaron S; Polinski, Jennifer M; Fulchino, Lisa A; Isaman, Danielle L; Gagne, Joshua J

    2015-04-01

    Generic drugs are approved on the basis of pharmaceutical equivalence and bioequivalence. Some drug products have unique structural or functional attributes, necessitating modified approaches to bioequivalence determinations. The aim of this systematic review was to identify studies that evaluated laboratory or clinical outcomes of six drugs approved via modified bioequivalence approaches. We conducted a systematic review of articles published through February 2014 in MEDLINE, EMBASE, and International Pharmaceutical Abstracts related to six recent drugs subject to modified regulatory approaches: venlafaxine extended release tablet (Effexor XR), acarbose (Precose), enoxaparin (Lovenox), vancomycin capsules (Vancocin), sodium ferric gluconate (Ferrlecit), and calcitonin salmon nasal spray (Miacalcin NS). We included all empirical evaluations (whether in vivo or in vitro) and excluded case studies, qualitative analyses, and pharmacoeconomic evaluations. Studies were summarized and evaluated on their methodological quality and assessed for bias using the Cochrane Risk of Bias Assessment Tool. Articles were divided into studies of US FDA-approved generics and non-FDA-approved generics available in non-US locations. We extracted drug(s) studied, study design, setting, sample size, population characteristics, study endpoints and results, and source of funding. After retrieving 1408 articles and searching through the full text of 106 articles, we found 26 articles that met our inclusion criteria-8 examining FDA-approved versions and 18 examining non-FDA-approved versions. Among FDA-approved generics, five studies of enoxaparin showed minor variations in biologic activities of unclear clinical importance, and no publications involved acarbose, venlafaxine ER, or vancomycin capsules. Among non-FDA-approved generics, nine studies of enoxaparin supported generic bioequivalence, despite three showing minor variations in drug activity. Four of six studies of venlafaxine ER

  13. The Food and Drug Administration advisory committees and panels: how they are applied to the drug regulatory process.

    Science.gov (United States)

    Ciociola, Arthur A; Karlstadt, Robyn G; Pambianco, Daniel J; Woods, Karen L; Ehrenpreis, Eli D

    2014-10-01

    Food and Drug Administration (FDA) advisory panels and committees play a critical role in advising the FDA on the safety and efficacy of medical devices and drugs marketed in the US. Advisory panel recommendations are used by the FDA to make decisions regarding medical products. Currently, the FDA utilizes over 50 advisory panels that serve the three major FDA centers, including the Centers for Biologics, Drugs and Device Products. Members of an advisory panel typically include academicians, clinicians, consumers, patients, and industry representatives. The FDA establishes the schedules for advisory panel meetings on an annual basis and a panel usually meets several times a year for two consecutive days in Washington, DC. Typically, the advisory panel discusses issues highlighted by the FDA and is then asked to vote a response to the questions posed in advance by the FDA. Advisory panel recommendations have a strong influence on FDA's decision to approve a product, as evidenced by the 214 Advisory Panels FDA convened between January 2008 to November 2012, during which advisory panel members voted to approve the product (or use of the product) ∼74% of the time, with FDA ultimately approving the medical product (or use of the product) ∼79% of the time. The ACG membership are encouraged to consider serving the public's interest by participating in an FDA advisory panel utilizing their expertise for the evaluation of a new drug or medical device, and providing advice about whether the product should be sold in the US.

  14. FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics

    National Research Council Canada - National Science Library

    Mantus, David; Pisano, Douglas J

    2008-01-01

    ...: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition are covered in a straightforward format. It is a compilation and commentary of selected laws and regulations pertaining to the development and approval of drugs, biologics, and medical devices in the United States. It is not intended to take the place of an actual r...

  15. 国外药品监管透明度研究综述%Review of Foreign Drug Regulatory Transparency

    Institute of Scientific and Technical Information of China (English)

    张新平; 曾丽; 刘云云

    2011-01-01

    目的:了解国外药品监管透明度的研究现状,为进一步的研究指明方向.方法:采用文献荟萃法对国外关于药品监管透明度的相关资料进行荟萃分析.结果:WHO、药品透明联盟、透明国际、美国等对药品监管透明度研究较多.WHO启动了药品良好治理项目,并开发了测量药品透明度的药品良好治理项目的评估工具;药品透明联盟关注于国家的药品政策、药品采购和供应链管理中的透明度的提高;透明国际组织侧重在药品腐败控制与透明度策略研究;美国FDA采取了一系列的措施提高医药行业的透明度.结论:药品监管透明度的研究有一定发展,但仍然很不完善:关于药品监管透明度具体测量方法的研究相对薄弱;提高药品监管透明度具体措施的研究不足;药品监管透明度的研究多为定性的探讨,缺乏定量分析和数据支撑.%Objectives: To have a comprehensive understanding of research status on the drug regulatory transparency. Methods: Searching the literatures related to drug regulatory transparency, then summarizing and analyzing them. Results: WHO, Medicines transparency alliance, transparency intemational, the U.S. and some scholars more studied the transparency of the drug regulatory. WHO launched the good govemance for medicines and developed its measurement tools. Medicines transparency alliance studied the increase of transparency in national drug policy, drug procurement and supply chain management. Transparency intemational focused on the drug corruption control and transparency strategy research. FDA adopted a series of measures to improve the transparency of the pharmaceutical industry. Conclusion: The theory research had great development, but it is still not perfect: the research about specific measurement methods of transparency is relatively weak; the research about the concrete measures of improve the transparency is insufficient; The research of the drug

  16. [Effect of proximate environment on drug susceptibility of mice (author's transl)].

    Science.gov (United States)

    Tanase, H; Matsunuma, N; Suzuki, Y

    1979-10-01

    The present study was performed in order to elucidate the effect of proximate environment on drug susceptibility of mice. Three experiments were carried out independently. In the first experiment, mongrel and ddS mice produced under an unsatisfactory control of proximate environment were purchased, and acute toxicity tests of thiamine hydrochloride (B1HCl) and isonicotinic acid hydrazide (INAH) were practiced at two different conditioned rooms. In the second experiment, ddY mice produced under the conventional environment controlled to a certain extent were purchased, and the toxic effect of B1HCl was examined under the similar environment. In the third experiment, the sensitivity to B1HCl of RFVL mice produced under the strict barrier system was tested at the severe air-conditioned room. LD50 and their fLD50 values were calculated by Litchfield-Wilcoxon's method, and the variance analyses were carried out. The severer the environmental control after the purchase of mice turned to the higher the drug sensitivity. This respect was more remarkable in INAH of which the toxic response is appeared slowly compared with B1HCl. Furthermore, seasonal variation was found in LD50 values. However, seasonal effect differed from rearing and experimental conditions. In the third experiment which these proximate environments were controlled severely, seasonal variation was very small. From the results of these experiments, it was defined that the use of animals produced under the satisfactory rearing condition and severe environmental control are necessary for animal experiments.

  17. Physiologically based pharmacokinetics in Drug Development and Regulatory Science: A workshop report (Georgetown University, Washington, DC, May 29–30, 2002)

    OpenAIRE

    Rowland, Malcolm; Balant, Luc; Peck,Carl

    2004-01-01

    A 2-day workshop on “Physiologically Based Pharmacokinetics (PBPK) in Drug Development and Regulatory Science” came to a successful conclusion on May 30, 2002, in Washington, DC. More than 120 international participants from the environmental and predominantly pharmaceutical industries, Food and Drug Administration (FDA), and universities attended this workshop, organized by the Center for Drug Development Science, Georgetown University, Washington, DC. The first of its kind specifically devo...

  18. Report on the use of non-clinical studies in the regulatory evaluation of oncology drugs.

    Science.gov (United States)

    Hayakawa, Yoshihiro; Kawada, Manabu; Nishikawa, Hiroyoshi; Ochiya, Takahiro; Saya, Hideyuki; Seimiya, Hiroyuki; Yao, Ryoji; Hayashi, Masahiro; Kai, Chieko; Matsuda, Akira; Naoe, Tomoki; Ohtsu, Atsushi; Okazaki, Taku; Saji, Hideo; Sata, Masataka; Sugimura, Haruhiko; Sugiyama, Yuichi; Toi, Masakazu; Irimura, Tatsuro

    2016-02-01

    Non-clinical studies are necessary at each stage of the development of oncology drugs. Many experimental cancer models have been developed to investigate carcinogenesis, cancer progression, metastasis, and other aspects in cancer biology and these models turned out to be useful in the efficacy evaluation and the safety prediction of oncology drugs. While the diversity and the degree of engagement in genetic changes in the initiation of cancer cell growth and progression are widely accepted, it has become increasingly clear that the roles of host cells, tissue microenvironment, and the immune system also play important roles in cancer. Therefore, the methods used to develop oncology drugs should continuously be revised based on the advances in our understanding of cancer. In this review, we extensively summarize the effective use of those models, their advantages and disadvantages, ranges to be evaluated and limitations of the models currently used for the development and for the evaluation of oncology drugs.

  19. Drug residues in animal tissues and their regulatory significance--the Canadian point of view.

    Science.gov (United States)

    Campbell, D J

    1978-09-01

    Today it is almost impossible to produce food of animal origin which is free from traces of drugs or chemicals. In Canada the problem of drug residues is controlled by a method of assessment of human safety which involves many factors. The toxicity of the drug in laboratory animals or, if possible, in man, is established and a no-effect dose is then estimated. These studies require oral administration of the drug and include acute, subacute, and teratogenicity studies. Depending on these results, chronic reproductive or carcinogenicity studies may be required before a no-effect dose can be estimated. Residue studies must encompass data on metabolism, pharmacokinetics, and depletion studies in edible tissues and for products such as milk and eggs. For veterinary drug residues, we must consider the target food animal with its particular metabolism, tissue disposition, and excretion patterns. The analytical method for residue detection must be acceptable and its sensitivity limits suitable for the drug and its major metabolites.

  20. [Clinical results of cefadroxil in children and pharmacokinetics of the drug (author's transl)].

    Science.gov (United States)

    Takimoto, M; Cho, K; Yoshioka, H; Sanae, N; Maruyama, S

    1981-02-01

    Cefadroxil was administered orally at a daily dose of 30-40 mg/kg to 8 cases of the infection of upper respiratory tract mainly due to beta-hemolytic Streptococcus, and efficacy was obtained in 7 cases, this rate being considered to be satisfactory, though the cases were too few to reach a conclusion. As to pathogens of bacterial infection of upper respiratory tract, beta-hemolytic Streptococcus and Staphylococcus aureus were encountered especially frequently, and in view of antibacterial activity against these 2 bacteria, our results could be approved. Further investigations should be performed carefully, however, to determine if cefadroxil may be a drug of first choice in the treatment of severe bacterial pneumonia and pyothorax. No side effects were observed throughout our treatment, though digestive tract disorders, especially diarrhea, are most frequent in literatures. As to pharmacokinetical characteristic of cefadroxil, almost the same results were obtained to other reports, though our data are insufficient as our experience was limited in only 1 case. Serum levels were determined after 35.7 mg/kg of cefadroxil were administered once orally, and a peak of about 38 mcg/ml appeared 2 hours later, and a high level of about 30 mcg/ml was maintained at 5 hours, though an oral dose was high. Efficacy for large area of bacterial infections may be expected from these serum levels. From urine collected simultaneously, about 74% of cefadroxil was recovered within more than 4 hours. This showed that cefadroxil was well absorbed from digestive tract, and a major part was excreted rapidly through kidney. From the results of our experiment, characteristics of cefadroxil may be summarized as follows. Cefadroxil is absorbed well after oral administration, antibacterial action is fully expected from serum level, a major part is excreted through kidney, and clearance is good. Cefadroxil will be recommended especially for bacterial infections of upper respiratory tract due to

  1. Use of lactobacilli and their pheromone-based regulatory mechanism in gene expression and drug delivery.

    Science.gov (United States)

    Diep, D B; Mathiesen, G; Eijsink, V G H; Nes, I F

    2009-01-01

    Lactobacilli are common microorganisms in diverse vegetables and meat products and several of these are also indigenous inhabitants in the gastro-intestinal (GI) tract of humans and animals where they are believed to have health promoting effects on the host. One of the highly appreciated probiotic effects is their ability to inhibit the growth of pathogens by producing antimicrobial peptides, so-called bacteriocins. Production of some bacteriocins has been shown to be strictly regulated through a quorum-sensing based mechanism mediated by a secreted peptide-pheromone (also called induction peptide; IP), a membrane-located sensor (histidine protein kinase; HPK) and a cytoplasmic response regulator (RR). The interaction between an IP and its sensor, which is highly specific, leads to activation of the cognate RR which in turn binds to regulated promoters and activates gene expression. The HPKs and RRs are built up by conserved modules, and the signalling between them within a network is efficient and directional, and can easily be activated by exogenously added synthetic IPs. Consequently, components from such regulatory networks have successfully been exploited in construction of a number of inducible gene expression systems. In this review, we discuss some well-characterised quorum sensing networks involved in bacteriocin production in lactobacilli, with special focus on the use of the regulatory components in gene expression and on lactobacilli as potential delivery vehicle for therapeutic and vaccine purposes.

  2. Authority of the Food and Drug Administration to require data access and control use rights in the Sentinel data network.

    Science.gov (United States)

    Evans, Barbara J

    2010-01-01

    The Food and Drug Administration Amendments Act of 2007 (FDAAA) authorized the U.S. Food and Drug Administration (FDA) to develop a 100-million-person health data network known as the Sentinel system. When fully operational, the Sentinel network will offer a very rich, very large health data resource that has the potential to become one of history's most powerful engines of biomedical innovation and clinical translation of discoveries. Who controls this asset will be a matter of great scientific and commercial importance. This article explores two key questions--data access and use rights--that are under debate as various parties jostle for control of the network: First, does FDA have legal authority to require private healthcare data environments--such as insurers, healthcare providers, pharmacists and other entities that hold data in administrative and clinical databases--to make data available for inclusion in the network? Second, who will decide how the network is used, once it is built? The article explains why a neutral analysis of these questions is essential as FDA designs the governance framework for protecting the diverse stakeholders who will be touched by the Sentinel network. The conclusion describes threats to network operations, including federal and state constitutional claims and state legislative interventions, which could arise if FDA fails to devote timely attention to these issues.

  3. Conflict of interest reporting by authors involved in promotion of off-label drug use: an analysis of journal disclosures.

    Directory of Open Access Journals (Sweden)

    Aaron S Kesselheim

    Full Text Available Litigation documents reveal that pharmaceutical companies have paid physicians to promote off-label uses of their products through a number of different avenues. It is unknown whether physicians and scientists who have such conflicts of interest adequately disclose such relationships in the scientific publications they author.We collected whistleblower complaints alleging illegal off-label marketing from the US Department of Justice and other publicly available sources (date range: 1996-2010. We identified physicians and scientists described in the complaints as having financial relationships with defendant manufacturers, then searched Medline for articles they authored in the subsequent three years. We assessed disclosures made in articles related to the off-label use in question, determined the frequency of adequate disclosure statements, and analyzed characteristics of the authors (specialty, author position and articles (type, connection to off-label use, journal impact factor, citation count/year. We identified 39 conflicted individuals in whistleblower complaints. They published 404 articles related to the drugs at issue in the whistleblower complaints, only 62 (15% of which contained an adequate disclosure statement. Most articles had no disclosure (43% or did not mention the pharmaceutical company (40%. Adequate disclosure rates varied significantly by article type, with commentaries less likely to have adequate disclosure compared to articles reporting original studies or trials (adjusted odds ratio [OR] = 0.10, 95%CI = 0.02-0.67, p = 0.02. Over half of the authors (22/39, 56% made no adequate disclosures in their articles. However, four of six authors with ≥ 25 articles disclosed in about one-third of articles (range: 10/36-8/25 [28%-32%].One in seven authors identified in whistleblower complaints as involved in off-label marketing activities adequately disclosed their conflict of interest in subsequent journal publications. This is

  4. Conflict of interest reporting by authors involved in promotion of off-label drug use: an analysis of journal disclosures.

    Science.gov (United States)

    Kesselheim, Aaron S; Wang, Bo; Studdert, David M; Avorn, Jerry

    2012-01-01

    Litigation documents reveal that pharmaceutical companies have paid physicians to promote off-label uses of their products through a number of different avenues. It is unknown whether physicians and scientists who have such conflicts of interest adequately disclose such relationships in the scientific publications they author. We collected whistleblower complaints alleging illegal off-label marketing from the US Department of Justice and other publicly available sources (date range: 1996-2010). We identified physicians and scientists described in the complaints as having financial relationships with defendant manufacturers, then searched Medline for articles they authored in the subsequent three years. We assessed disclosures made in articles related to the off-label use in question, determined the frequency of adequate disclosure statements, and analyzed characteristics of the authors (specialty, author position) and articles (type, connection to off-label use, journal impact factor, citation count/year). We identified 39 conflicted individuals in whistleblower complaints. They published 404 articles related to the drugs at issue in the whistleblower complaints, only 62 (15%) of which contained an adequate disclosure statement. Most articles had no disclosure (43%) or did not mention the pharmaceutical company (40%). Adequate disclosure rates varied significantly by article type, with commentaries less likely to have adequate disclosure compared to articles reporting original studies or trials (adjusted odds ratio [OR] = 0.10, 95%CI = 0.02-0.67, p = 0.02). Over half of the authors (22/39, 56%) made no adequate disclosures in their articles. However, four of six authors with ≥ 25 articles disclosed in about one-third of articles (range: 10/36-8/25 [28%-32%]). One in seven authors identified in whistleblower complaints as involved in off-label marketing activities adequately disclosed their conflict of interest in subsequent journal publications. This is a much

  5. A Critical Review of Biosimilars in IBD: The Confluence of Biologic Drug Development, Regulatory Requirements, Clinical Outcomes, and Big Business.

    Science.gov (United States)

    Ha, Christina Y; Kornbluth, Asher

    2016-10-01

    On February 9, 2016, the Food and Drug Administration Arthritis Advisory Committee recommended by a vote of 21 to 3, that the biosimilar to infliximab, CT-P13, be approved for rheumatoid arthritis and ankylosing spondylitis and, by extrapolation, for all the indications for which infliximab is currently approved, including adult and pediatric ulcerative colitis and Crohn's disease. On April 5, 2016, the Food and Drug Administration concurred with this recommendation and approved CT-P13 (Inflectra; Pfizer Inc.) for all diseases for which infliximab had previously been approved, including adult and pediatric moderate to severe ulcerative colitis and pediatric and adult moderate to severe and fistulizing Crohn's disease. This was despite the absence of any randomized controlled trials studying the infliximab biosimilar in any inflammatory bowel disease. This highly controversial approach has been criticized by various rheumatology and gastroenterology professional societies around the world. This review will cover the stepwise approach to biosimilar development, issues of extrapolation and interchangeability, and conclude with a discussion of the regulatory, intellectual property issues, and financial implications, which will all intersect in the decision and ability to prescribe a biosimilar or reference anti-tumor necrosis factor drug.

  6. Actions of the Cuban Nuclear Regulatory Authority in the adequate implementation of the legislation in matter of radiological protection; Acciones de la Autoridad Reguladora Nuclear cubana en la adecuada implementacion de la Legislacion en materia de proteccion radiologica

    Energy Technology Data Exchange (ETDEWEB)

    Fornet R, O.M. [Delegacion Territorial CITMA. Peralta No.16, Rpto Peralta, Holguin, CP 80400 (Cuba); Guillen C, A.; Betancourt H, L.A. [Centro Nacional de Seguridad Nuclear, Calle 28 No.504, Miramar Playa, La Habana (Cuba)]. e-mail: ofelia@citmahlg.holguin.inf.cu

    2006-07-01

    The effectiveness of the regulatory activity in matter of safety and radiological protection it depends in great measure of the practical implementation level of the legislation in this matter. In our country this objective has been achieved through the one continuous improvement of the Hierarchical System of Nuclear Regulation, the reconciliation with specialists and national experts in each matter during the elaboration of the legal documents; the popularization and gratuitous distribution of it approved; the precision in the validation conditions of the authorizations of those main precepts applicable to the practices; the legal foundation of the deficiencies evidenced in the regulatory inspections; the development of a Safety Culture; the realization of Annual Regulatory Conferences and mainly in the training of the personnel related with the safety. Also, the constant analysis on the part of the specialists of the Regulatory Authority of the grade of implementation of this legislation, it discussion in national and international events and the actions recommended in these works. As a result of this focus, it is considered that the Regulatory Authority has impacted appropriately in the implementation of this legislation. (Author)

  7. The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update.

    Science.gov (United States)

    Elahi, Merina; Eshera, Noha; Bambata, Nkosazana; Barr, Helen; Lyn-Cook, Beverly; Beitz, Julie; Rios, Maria; Taylor, Deborah R; Lightfoote, Marilyn; Hanafi, Nada; DeJager, Lowri; Wiesenfeld, Paddy; Scott, Pamela E; Fadiran, Emmanuel O; Henderson, Marsha B

    2016-03-01

    The U.S. Food and Drug Administration Office of Women's Health (FDA OWH) has supported women's health research for ∼20 years, funding more than 300 studies on women's health issues, including research on diseases/conditions that disproportionately affect women in addition to the evaluation of sex differences in the performance of and response to medical products. These important women's health issues are studied from a regulatory perspective, with a focus on improving and optimizing medical product development and the evaluation of product safety and efficacy in women. These findings have influenced industry direction, labeling, product discontinuation, safety notices, and clinical practice. In addition, OWH-funded research has addressed gaps in the knowledge about diseases and medical conditions that impact women across the life span such as cardiovascular disease, pregnancy, menopause, osteoporosis, and the safe use of numerous medical products.

  8. Marketing Authorization Procedures for Advanced Cancer Drugs: Exploring the Views of Patients, Oncologists, Healthcare Decision Makers, and Citizens in France.

    Science.gov (United States)

    Protiére, Christel; Baker, Rachel; Genre, Dominique; Goncalves, Anthony; Viens, Patrice

    2017-07-01

    The past decades have seen advances in cancer treatments in terms of toxicity and side effects but progress in the treatment of advanced cancer has been modest. New drugs have emerged improving progression free survival but with little impact on overall survival, raising questions about the criteria on which to base decisions to grant marketing authorizations and about the authorization procedure itself. For decisions to be fair, transparent and accountable, it is necessary to consider the views of those with relevant expertise and experience. We conducted a Q-study to explore the views of a range of stakeholders in France, involving: 54 patients (18 months after diagnosis); 50 members of the general population; 27 oncologists; 19 healthcare decision makers; and 2 individuals from the pharmaceutical industry. Three viewpoints emerged, focussing on different dimensions entitled: 1) 'Quality of life (QoL), opportunity cost and participative democracy'; 2)'QoL and patient-centeredness'; and 3) 'Length of life'. Respondents from all groups were associated with each viewpoint, except for healthcare decision makers, who were only associated with the first one. Our results highlight plurality in the views of stakeholders, emphasize the need for transparency in decision making processes, and illustrate the importance of a re-evaluation of treatments for all 3 viewpoints. In the context of advanced cancer, our results suggest that QoL should be more prominent amongst authorization criteria, as it is a concern for 2 of the 3 viewpoints.

  9. Probiotic foods and drugs: impact of US regulatory status on design of clinical trials.

    Science.gov (United States)

    Hibberd, Patricia L; Davidson, Lisa

    2008-02-01

    Probiotics have been in widespread use since ancient times and are increasingly being consumed to maintain health and to prevent and treat a wide range of conditions. In the United States, probiotics are considered to be foods or biologics, depending on their intended use. This article addresses the similarities and differences between approaches to conducting clinical trials of probiotics as foods (which leads to health claims) or as biologics (which leads to therapeutic claims). Most probiotics are manufactured as foods, which makes it challenging for academic investigators in the United States to meet the requirements of an Investigational New Drug application that enables them to study the therapeutic effects of these novel agents. Although it is important to ensure the safety and quality of probiotic products, there also may be value in adapting the US Food and Drug Administration's Guidance for Industry for Botanical Products to probiotic products, in part to allow the research agenda to move forward with products for which there are no safety concerns.

  10. Inflation of the type I error: investigations on regulatory recommendations for bioequivalence of highly variable drugs.

    Science.gov (United States)

    Wonnemann, Meinolf; Frömke, Cornelia; Koch, Armin

    2015-01-01

    We investigated different evaluation strategies for bioequivalence trials with highly variable drugs on their resulting empirical type I error and empirical power. The classical 'unscaled' crossover design with average bioequivalence evaluation, the Add-on concept of the Japanese guideline, and the current 'scaling' approach of EMA were compared. Simulation studies were performed based on the assumption of a single dose drug administration while changing the underlying intra-individual variability. Inclusion of Add-on subjects following the Japanese concept led to slight increases of the empirical α-error (≈7.5%). For the approach of EMA we noted an unexpected tremendous increase of the rejection rate at a geometric mean ratio of 1.25. Moreover, we detected error rates slightly above the pre-set limit of 5% even at the proposed 'scaled' bioequivalence limits. With the classical 'unscaled' approach and the Japanese guideline concept the goal of reduced subject numbers in bioequivalence trials of HVDs cannot be achieved. On the other hand, widening the acceptance range comes at the price that quite a number of products will be accepted bioequivalent that had not been accepted in the past. A two-stage design with control of the global α therefore seems the better alternative.

  11. Information on new drugs at market entry: retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry reports

    Science.gov (United States)

    Köhler, Michael; Haag, Susanne; Biester, Katharina; Brockhaus, Anne Catharina; McGauran, Natalie; Grouven, Ulrich; Kölsch, Heike; Seay, Ulrike; Hörn, Helmut; Moritz, Gregor; Staeck, Kerstin

    2015-01-01

    Background When a new drug becomes available, patients and doctors require information on its benefits and harms. In 2011, Germany introduced the early benefit assessment of new drugs through the act on the reform of the market for medicinal products (AMNOG). At market entry, the pharmaceutical company responsible must submit a standardised dossier containing all available evidence of the drug’s added benefit over an appropriate comparator treatment. The added benefit is mainly determined using patient relevant outcomes. The “dossier assessment” is generally performed by the Institute for Quality and Efficiency in Health Care (IQWiG) and then published online. It contains all relevant study information, including data from unpublished clinical study reports contained in the dossiers. The dossier assessment refers to the patient population for which the new drug is approved according to the summary of product characteristics. This patient population may comprise either the total populations investigated in the studies submitted to regulatory authorities in the drug approval process, or the specific subpopulations defined in the summary of product characteristics (“approved subpopulations”). Objective To determine the information gain from AMNOG documents compared with non-AMNOG documents for methods and results of studies available at market entry of new drugs. AMNOG documents comprise dossier assessments done by IQWiG and publicly available modules of company dossiers; non-AMNOG documents comprise conventional, publicly available sources—that is, European public assessment reports, journal publications, and registry reports. The analysis focused on the approved patient populations. Design Retrospective analysis. Data sources All dossier assessments conducted by IQWiG between 1 January 2011 and 28 February 2013 in which the dossiers contained suitable studies allowing for a full early benefit assessment. We also considered all European public assessment

  12. Rewiring drug-activated p53-regulatory network from suppressing to promoting tumorigenesis

    Institute of Scientific and Technical Information of China (English)

    Wei Song; Jiguang Wang; Ying Yang; Naihe Jing; Xiangsun Zhang; Luonan Chen; Jiarui Wu

    2012-01-01

    Many of oncogenes and tumor suppressor genes have been found to exert variable and even opposing roles in different kinds of tumors or at different stages of cancer development.Here we showed that tumorigenic potential of mouse embryonic carcinoma P19 cells cultured in adherent plates (attached-P19-cells) was suppressed by a chemotherapeutic agent,5-aza-2'-deoxycytidine (ZdCyd),whereas the higher pro-tumorigenicity of P19 cells growing in suspension (detached-P19-cells) was generated by the ZdCyd treatment.Surprisingly,p53 activity was highly up-regulated by ZdCyd in both growing conditions.By our developed computational approaches,we revealed that there was a significant enrichment of apoptotic pathways in the ZdCyd-induced p53-dominant gene-regulatory network in attached P19 cells,whereas the pro-survival genes were significantly enriched in the ZdCyd-induced p53 network in detached P19 cells.The protein-protein interaction network of the ZdCyd-treated detached P19 cells was significantly different from that of ZdCyd-treated attached P19 cells.On the other hand,inhibition of pS3 expression by siRNA suppressed the ZdCyd-induced tumorigenesis of detached P19 cells,suggesting that the ZdCyd-activated p53 plays oncogenic function in detached P19 cells.Taken together,these results indicate a context-dependent role for the ZdCyd-activated p53-dominant network in tumorigenesis.

  13. Incorporating patient preferences into drug development and regulatory decision making: Results from a quantitative pilot study with cancer patients, carers, and regulators.

    Science.gov (United States)

    Postmus, D; Mavris, M; Hillege, H L; Salmonson, T; Ryll, B; Plate, A; Moulon, I; Eichler, H-G; Bere, N; Pignatti, F

    2016-05-01

    Currently, patient preference studies are not required to be included in marketing authorization applications to regulatory authorities, and the role and methodology for such studies have not been agreed upon. The European Medicines Agency (EMA) conducted a pilot study to gain experience on how the collection of individual preferences can inform the regulatory review. Using a short online questionnaire, ordinal statements regarding the desirability of different outcomes in the treatment of advanced cancer were elicited from 139 participants (98 regulators, 29 patient or carers, and 12 healthcare professionals). This was followed by face-to-face meetings to gather feedback and validate the individual responses. In this article we summarize the EMA pilot study and discuss the role of patient preference studies within the regulatory review. Based on the results, we conclude that our preference elicitation instrument was easy to implement and sufficiently precise to learn about the distribution of the participants' individual preferences.

  14. Regulatory verification on safe use of cytotoxic drugs in veterinary clinics and animal hospitals.

    Science.gov (United States)

    Fung, V; Seneviratne, M

    2016-11-01

    Veterinarians are increasingly being asked to provide chemotherapy for veterinary patients. However, chemotherapy agents have cytotoxic effects that can pose a health risk to workers from exposure. There are no published studies examining cytotoxic drug (CTD) contamination in veterinary practices in Australia. CTD use at 13 veterinary clinics and animal hospitals across New South Wales (NSW) was verified for compliance with Work, Health and Safety (WHS) legislation on the effectiveness of exposure control measures. Surface swab sampling was performed to detect the restricted carcinogen cyclophosphamide and seven other CTD. A total of 73 surface swab samples were collected from nine locations associated with CTD delivery, storage, treatment and waste disposal at four veterinary practices, with repeat sampling at two veterinary practices. Compliance with WHS legislation for systematic chemical management, including procedures for safe use of carcinogens, in veterinary practices was high: 4 of the 10 key clauses in WHS chemical management were complied with at all 13 verified workplaces. Surface contamination was detected in three locations, with levels of CTD contaminants ranging from 3.54 to 89 ng per sample. Results showed that, in general, there were safe systems in place to work with CTD in the veterinary practices that were verified in NSW. Areas for improvement were mainly in administrative measures related to hazardous chemical management. Particular attention should be given to raising awareness of the intrinsic hazards of CTD, through training and hazard information provision to staff. © 2016 Australian Veterinary Association.

  15. Clinical research: regulatory issues.

    Science.gov (United States)

    Wermeling, D P

    1999-02-01

    The regulatory issues faced by institutions performing clinical research are described. Many institutions do not have on staff an expert who understands the regulatory issues involved in managing investigational new drug research and who knows the institution's obligations under the federal rules. Because pharmacists understand the FDA regulations that apply to the management of drugs in clinical research, institutions are asking pharmacists to expand their role and manage clinical research offices. Many authorities govern various aspects of investigational drug research. FDA has published regulations for good clinical practice (GCP), and the International Conference on Harmonisation is developing an international standard for the proper management of clinical trials. The guidelines published by the Joint Commission on Accreditation of Healthcare Organizations aim to protect patients who are in the institution to receive health care and also participate in clinical trials. The Social Security Administration Acts specifically state that only items and services that are reasonable and necessary for the diagnosis and treatment of injury or disease can be billed to the government; research-related billings are excluded from coverage. Proper management of drug research is crucial to the success of a research program that is integrated with patient care.

  16. German Kava Ban Lifted by Court: The Alleged Hepatotoxicity of Kava (Piper methysticum) as a Case of Ill-Defined Herbal Drug Identity, Lacking Quality Control, and Misguided Regulatory Politics.

    Science.gov (United States)

    Kuchta, Kenny; Schmidt, Mathias; Nahrstedt, Adolf

    2015-12-01

    Kava, the rhizome and roots of Piper methysticum, are one of the most important social pillars of Melanesian societies. They have been used for more than 1000 years in social gatherings for the preparation of beverages with relaxing effects. During the colonial period, extract preparations found their way into Western medicinal systems, with experience especially concerning the treatment of situational anxiety dating back more than 100 years. It therefore came as a surprise when the safety of kava was suddenly questioned based on the observation of a series of case reports of liver toxicity in 1999 and 2000. These case reports ultimately led to a ban of kava products in Europe - a ban that has been contested because of the poor evidence of risks related to kava. Only recently, two German administrative courts decided that the decision of the regulatory authority to ban kava as a measure to ensure consumer safety was inappropriate and even associated with an increased risk due to the higher risk inherent to the therapeutic alternatives. This ruling can be considered as final for at least the German market, as no further appeal has been pursued by the regulatory authorities. However, in order to prevent further misunderstandings, especially in other markets, the current situation calls for a comprehensive presentation of the cardinal facts and misconceptions concerning kava and related drug quality issues.

  17. Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness.

    Science.gov (United States)

    Kesselheim, Aaron S; Gagne, Joshua J

    2015-10-01

    Generic drugs possessing the same active ingredients, dosage form, strength, route of administration, and labeling can be approved by the US Food and Drug Administration (FDA) as interchangeable with a brand-name drug without needing to repeat the formal Phase I, II, and III clinical trials conducted by the original manufacturers. In recent years, the FDA has approved several generic drugs using product-specific testing to determine therapeutic equivalence in accordance with the unique features of the particular drug. These have been used in two primary situations: (1) cases for which certain bioequivalence studies were not relevant; and (2) cases of complex molecules that may require specially tailored pharmaceutical equivalence studies. Examples include venlafaxine extended release, acarbose, vancomycin capsules, sodium ferric gluconate, salmon calcitonin nasal spray, and enoxaparin. Product-specific approaches to demonstrating therapeutic equivalence are essential to avoid delays in low-cost generic drug availability but can have important clinical implications; yet, currently, there is no formal process in place to monitor the safety and effectiveness of generic drugs approved using modified regulatory pathways. Several strategies can be used to monitor the safety and effectiveness of generic drugs approved via product-specific determinations of therapeutic equivalence.

  18. Update on medical and regulatory issues pertaining to compounded and FDA-approved drugs, including hormone therapy

    OpenAIRE

    Pinkerton, JoAnn V; Pickar, James H.

    2016-01-01

    Abstract Objective: We review the historical regulation of drug compounding, concerns about widespread use of non-Food and Drug Admiistration (FDA)-approved compounded bioidentical hormone therapies (CBHTs), which do not have proper labeling and warnings, and anticipated impact of the 2013 Drug Quality and Security Act (DQSA) on compounding. Methods: US government websites were searched for documents concerning drug compounding regulation and oversight from 1938 (passage of Federal Food, Drug...

  19. Mind the gap: predicting cardiovascular risk during drug development

    OpenAIRE

    Chain, Anne S Y

    2012-01-01

    Cardiovascular safety issues, specifically drug-induced QT/QTc-interval prolongation, remain a major cause of drug attrition during clinical development and is one of the main causes for post-market drug withdrawals accounting for 15-34% of all drug discontinuation. Given the potentially fatal consequences of this concentration-dependent adverse drug reaction, regulatory authorities have reacted to this “pharmacoepidemic” by denying or delaying the approval of a number of new drugs and placin...

  20. Oseltamivir prescription and regulatory actions vis-a-vis abnormal behavior risk in Japan: drug utilization study using a nationwide pharmacy database.

    Directory of Open Access Journals (Sweden)

    Hisashi Urushihara

    Full Text Available BACKGROUND: In March 2007, a regulatory advisory was issued in Japan to restrict oseltamivir use in children aged 10-19 years because of safety concerns over abnormal behavior. The effectiveness and validity of regulatory risk minimization actions remain to be reviewed, despite their significant public health implications. To assess the impact of the regulatory actions on prescribing practices and safety reporting. METHODOLOY/PRINICPAL FINDINGS: In this retrospective review of a nationwide pharmacy database, we analyzed 100,344 dispensation records for oseltamivir and zanamivir for the period from November 2006 to March 2009. The time trend in dispensations for these antiviral agents was presented before and after the regulatory actions, contrasted with intensity of media coverage and the numbers of spontaneous adverse reaction reports with regard to antivirals. The 2007 regulatory actions, together with its intense media coverage, reduced oseltamivir dispensation in targeted patients in fiscal year 2008 to 20.4% of that in fiscal year 2006, although influenza activities were comparable between these fiscal years. In contrast, zanamivir dispensation increased approximately nine-fold across all age groups. The number of abnormal behavior reports associated with oseltamivir in children aged 10-19 years decreased from fiscal year 2006 to 2008 (24 to 9 cases; this decline was offset by the increased number of reports of abnormal behavior in children under age 10 (12 to 28 cases. The number of reports associated with zanamivir increased in proportion to increased dispensation of this drug (11 to 114 cases. CONCLUSIONS/SIGNIFICANCE: The 2007 actions effectively reduced oseltamivir prescriptions and the number of reports of abnormal behavior in the targeted group. The observed increase in abnormal behavior reports in oseltamivir patients under age 10 and in zanamivir patients suggests that these patient groups may also be at risk, calling into question

  1. [Experimental Subarachnoid hemmorrhage in dogs--effect of various drugs and sympathectomy on cerebral arterial spasm (author's transl)].

    Science.gov (United States)

    Noda, S

    1975-09-01

    Adult mongrel dogs were used. The posterior communicating artery was punctured with a fine needle and subarachnoid hemorrhage was produced, which simulated aneurysmal rupture in human. The cerebral basal arteries were constricted remarkably after the puncture. However this vasospasm disappeared in about 60-120 minutes. After this restoration, the vessels began to be constricted again and reduced their diameter in greater degree with lapse of time. Effect of various drugs and sympathectomy on the experimental spasm induced by this method were studied utilizing the magnified vertebral angiography. The drugs used were papverine, isoxuprine, methysergide, phentolamine and propranolol. One of these drugs was given to each dog into the vertebral artery 15 minutes after the puncture of the artery for study of the early spasm, and the same procedure was carried out 24 hours after the late spasm. Vertebral arteriograms were taken immediately after and at 5, 10 and 30 minutes after injection of the drug. Diameter changes of the cerebral basal arteries were measured on the film. Smooth muscle relaxtants, papaverine and isoxsuprine, were effective on relieving the early and the late spasm. An antiserotonin agent, methysergide, relieved slightly the early spasm, but it had no effect on the late spasm. Phentolamine, that is an adrenergic blocking agent, relieved the early spam remarkably, but it was less effective on the late spam. A beta adrenergic blocking agent, propranolol, was effective on relieving neither the early nor the late spasm. Two weeks after the removal of the bilateral upper cervical ganglia, subarachnoid hemorrhage was produced by the smae method as mentioned above in four dogs. Arteriograms taken 24 hours after puncture of the posterior communicating artery in these dogs showed vasoconstriction as same as in the non-sympathectomized dogs. From these experimental results, it was suggested that an etiological difference in the early and the late spasm may exist

  2. Use of Fixed Dose Combination (FDC Drugs in India: Central Regulatory Approval and Sales of FDCs Containing Non-Steroidal Anti-Inflammatory Drugs (NSAIDs, Metformin, or Psychotropic Drugs.

    Directory of Open Access Journals (Sweden)

    Patricia McGettigan

    2015-05-01

    Full Text Available In 2012, an Indian parliamentary committee reported that manufacturing licenses for large numbers of fixed dose combination (FDC drugs had been issued by state authorities without prior approval of the Central Drugs Standard Control Organization (CDSCO in violation of rules, and considered that some ambiguity until 1 May 2002 about states' powers might have contributed. To our knowledge, no systematic enquiry has been undertaken to determine if evidence existed to support these findings. We investigated CDSCO approvals for and availability of oral FDC drugs in four therapeutic areas: analgesia (non-steroidal anti-inflammatory drugs [NSAIDs], diabetes (metformin, depression/anxiety (anti-depressants/benzodiazepines, and psychosis (anti-psychotics.This was an ecologic study with a time-trend analysis of FDC sales volumes (2007-2012 and a cross-sectional examination of 2011-2012 data to establish the numbers of formulations on the market with and without a record of CDSCO approval ("approved" and "unapproved", their branded products, and sales volumes. Data from the CDSCO on approved FDC formulations were compared with sales data from PharmaTrac, a database of national drug sales. We determined the proportions of FDC sales volumes (2011-2012 arising from centrally approved and unapproved formulations and from formulations including drugs banned/restricted internationally. We also determined the proportions of centrally approved and unapproved formulations marketed before and after 1 May 2002, when amendments were made to the drug rules. FDC approvals in India, the United Kingdom (UK, and United States of America (US were compared. For NSAID FDCs, 124 formulations were marketed, of which 34 (27% were centrally approved and 90 (73% were unapproved; metformin: 25 formulations, 20 (80% approved, five (20% unapproved; anti-depressants/benzodiazepines: 16 formulations, three (19% approved, 13 (81% unapproved; anti-psychotics: ten formulations, three (30

  3. Proyecto Grannacional ALBASALUD para Centro Regulador de Medicamentos Esenciales de los países del ALBA-TCP Grand-national Project ALBASALUD for Regulatory Center of Essential Drugs for the ALBA-TCP countries

    Directory of Open Access Journals (Sweden)

    Celeste Aurora Sánchez González

    2011-09-01

    Full Text Available La Autoridad Reguladora de Medicamentos de Cuba, coordina un Proyecto de la Alianza Bolivariana para los pueblos de América-Tratado de Libre Comercio (ALBA-TCP, dirigido al desarrollo de un Centro Regulador para los países del ALBA como nuevo organismo regional de integración farmacéutica, en aras de contar con un Registro Grannacional válido en todos los países partes, como herramienta para facilitar el acceso a medicamentos esenciales de calidad. Esta investigación tuvo como objetivo diseñar y conducir desde el punto de vista técnico un proyecto para crear las bases legales y metodológicas del futuro centro y sus funciones básicas. Se emplearon técnicas de grupo nominal, puntos de referencia, consultas a expertos y se crearon metodologías específicas para planear y confeccionar los documentos necesarios. Se utilizaron lineamientos de organismos reguladores internacionales, cuadros básicos de medicamentos y reglamentación farmacéutica de los países participantes. Se desarrollaron y aplicaron documentos y estrategias para el trabajo del proyecto durante la etapa de preinversión, se definió el primer listado de medicamentos esenciales del ALBA y se aprobaron las fundamentales disposiciones legales y la reglamentación para las funciones de registro, vigilancia, inspecciones, laboratorios y liberación de lotes. El Proyecto Grannacional ALBASALUD "Centro Regulador de Medicamentos del ALBA-TCP" aplicado ha demostrado su eficiencia y capacidad para alcanzar los objetivos trazados mediante un trabajo científico-técnico con participación colectiva, que ha garantizado las disposiciones y lineamientos requeridos para sus funciones básicas y respaldo legal.The Drug Regulatory Authority of Cuba is coordinating a Project of the Bolivarian Alliance for the Peoples of America- Free Trade Agreement (ALBA-TCP aimed at developing a Regulatory Center that will operate as a new regional body of pharmaceutical integration for the ALBA

  4. Current Scientific and Regulatory Approaches for Development of Orally Inhaled and Nasal Drug Products: Overview of the IPAC-RS/University of Florida Orlando Inhalation Conference.

    Science.gov (United States)

    Hochhaus, Guenther; Davis-Cutting, Craig; Oliver, Martin; Lee, Sau L; Lyapustina, Svetlana

    2015-09-01

    This article summarizes discussions at the March 2014 conference organized by the University of Florida (UF) and International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), entitled "Orlando Inhalation Conference: Approaches in International Regulation." The special focus of the conference was on global scientific and regulatory issues associated with the testing and demonstration of equivalence for the registration of orally inhaled drug products (OIDPs) in the United States, Europe, Brazil, China, and India. The scope included all types of OIDPs throughout their lifecycle, e.g., innovator/brand-name products, generics, modifications due to lifecycle management, device changes, etc. Details were presented for the U.S. "weight of evidence approach" for registration of generic products (which includes demonstration of in vitro and in vivo equivalence, as well as quantitative and qualitative sameness, and device similarity). The European "stepwise" approach was elucidated, and the thinking of regulatory agencies in the major emerging markets was clarified. The conference also highlighted a number of areas that would benefit from further research and discussion, especially around patient/device interface and human factor studies, statistical methods and criteria for demonstrating equivalence, the relative roles of in vivo and in vitro tests, and appropriate designs and metrics for in vivo studies of inhaled drugs.

  5. Potential use of DNA barcodes in regulatory science: identification of the U.S. Food and Drug Administration's "Dirty 22," contributors to the spread of foodborne pathogens.

    Science.gov (United States)

    Jones, Yolanda L; Peters, Sharla M; Weland, Chris; Ivanova, Natalia V; Yancy, Haile F

    2013-01-01

    The U.S. Food, Drug, and Cosmetic Act prohibits the distribution of food that is adulterated, and the regulatory mission of the U.S. Food and Drug Administration (FDA) is to enforce this Act. FDA field laboratories have identified the 22 most common pests that contribute to the spread of foodborne disease (the "Dirty 22"). The current method of detecting filth and extraneous material (tails, legs, carcasses, etc.) is visual inspection using microscopy. Because microscopy can be time-consuming and may yield inaccurate and/or nonspecific results due to lack of expertise, an alternative method of detecting these adulterants is needed. In this study, we sequenced DNA from the 5' region of the cytochrome oxidase I gene of these 22 common pests that contribute to the spread of foodborne pathogens. Here, we describe the generation of DNA barcodes for all 22 species. To date, this is the first attempt to develop a sequence-based regulatory database and systematic primer strategy to identify these FDA-targeted species. DNA barcoding can be a powerful tool that can aid the FDA in promoting the protection and safety of the U.S. food supply.

  6. Regulatory considerations for biosimilars

    Directory of Open Access Journals (Sweden)

    Ranjani Nellore

    2010-01-01

    Full Text Available Currently there is considerable interest in the legislative debate around generic biological drugs or "biosimilars" in the EU and US due to the large, lucrative market that it offers to the industry. While some countries have issued a few regulatory guidelines as well as product specific requirements, there is no general consensus as to a single, simple mechanism similar to the bioequivalence determination that leads to approval of generic small molecules all over the world. The inherent complex nature of the molecules, along with complicated manufacturing and analytical techniques to characterize them make it difficult to rely on a single human pharmacokinetic study for assurance of safety and efficacy. In general, the concept of comparability has been used for evaluation of the currently approved "similar" biological where a step by step assessment on the quality, preclinical and clinical aspects is made. In India, the focus is primarily on the availability and affordability of life-saving drugs. In this context every product needs to be evaluated on its own merit irrespective of the innovator brand. The formation of the National Biotechnology Regulatory Authority may provide a step in the right direction for regulation of these complex molecules. However, in order to have an efficient machinery for initial approval and ongoing oversight with a country-specific focus, cooperation with international authorities for granting approvals and continuous risk-benefit review is essential. Several steps are still needed for India to be perceived as a country that leads the world in providing quality biological products.

  7. [Compared efficacies of somes antispasmodic drugs on the digestive tract and the bladder of the anesthetized dog (author's transl)].

    Science.gov (United States)

    Dureng, G; Boero, C; Meunier, A; Labrid, C

    1981-01-01

    The antispasmodic activity of tiemonium, mebeverine, pitofenone + fenpiverinium association and N-butyl scopolammonium was compared in the anesthetized dog. Strain gauges were fixed on the gastric antro-fundic border, on the pylorus, on the descending duodenum and on the terminal colon. Pressure transducers were connected with water filled small balloons inserted into the gall bladder and the bladder. Five minutes after the intra-venous injection of the drugs, contraction of the smooth musculature was induced by 3 intra-venous injections of BaCl2 (1 mg.kg(-1)) at 3 minutes intervals. The results were expressed as ED50 values (mg.kg(-1)). 2. Tiemonium was the most potent of the 4 antispasmodic drugs. Its ED50 values were very similar for the different organs, ranging from 0.13 +/- 0.022 for the duodenum to 0.31 +/- 0.03 for the bladder. Mebeverine and pitofenone + fenpiverinium association were equipotent but for colon contraction, where mebeverine was more active (ED50 = 0.68 +/- 0.06). Other ED50 relatives to these 2 compounds were ranging from 0.40 +/- 0.02 (duodenum) to 1.32 +/- 0.14 (gall bladder). N-butyl scopolammonium was found to be the weakest antispasmodic drug on this model. Its activity was very weak on colon (ED50 = 5.21 +/- 0.037), gall bladder (ED50 = 5.40 +/- 0.074) and bladder (ED50 = 5.02 +/- 0.059). 3. The strong antispasmodic activity demonstrated on this model with tiemonium seems to be due to its potent inhibition of membrane Ca++ ions, added to its moderate anticholinergic activity.

  8. New antirheumatic drugs: any real added value? A critical overview of regulatory criteria for their marketing approval.

    Science.gov (United States)

    Bertele', Vittorio; Assisi, Alessandro; Di Muzio, Valeria; Renzo, Danila; Garattini, Silvio

    2007-09-01

    Rheumatoid arthritis (RA) is a systemic autoimmune disorder causing chronic polyarticular synovial inflammation and progressive joint damage. New anti-rheumatic drugs, such as leflunomide, infliximab, etanercept, adalimumab and anakinra, have recently become available. The aim of this paper is to summarize and critically evaluate the type of studies and clinical endpoints accepted by the European Medicines Agency (EMEA) to approve these new drugs. Information regarding the approval of antirheumatic drugs was obtained from European Public Assessment Reports (EPARs) and published pivotal studies. Leflunomide is the only non-biological disease-modifying anti-rheumatic drug (DMARD) to receive recent approval for RA treatment, but strong evidence of its superiority over conventional therapies is lacking. Anakinra in combination with methotrexate received approval as a DMARD for RA on the basis of two pivotal trials in which American College of Rheumatology response criteria (ACR 20 response) were used as the sole primary endpoint. For easier demonstration of efficacy, studies leading to first approval of etanercept, infliximab and adalimumab were carried out on non-responders to DMARDs. Once on the market, these drugs gained an extension of the indication to methotrexate-naïve patients. Studies that provided the basis for approval were not adequately designed, given the lack of an active control and the choice of ACR response as the only clinical endpoint. Consequently, only a weak proof of efficacy emerged for the treatment of signs and symptoms of RA, and these drugs failed to show real benefit in slowing radiographic progression. Serious infections, changes in blood cell counts, severe skin and hepatic infections were the main adverse events that emerged from the clinical studies. Therefore, the unconvincing benefit of the new antirheumatic drugs can scarcely outweigh the risk associated with their use. Moreover, the monthly costs in Italy of the new biological

  9. From evidence-based to hope-based medicine? Ethical aspects on conditional market authorization of and early access to new cancer drugs.

    Science.gov (United States)

    Sandman, Lars; Liliemark, Jan

    2017-08-01

    There is a strong patient demand for early access to potentially beneficial cancer drugs. In line with this authorization agencies like the European Medicines Agency are providing drugs with conditional market authorisation based on positive interim analyses. This implies that drugs are used with insecure evidence of efficacy and adverse side-effects. Several authors have pointed to ethical problems with such a system but up to date no indepth ethical analysis of this system is found which is the aim of this article. Drawing of the four generally accepted principles of medical ethics: beneficence, nonmaleficence, respect for autonomy and justice the ethical pros and cons of conditional market authorisation are analysed. From the perspective of beneficence and non-maleficence it is found that the main problem is not risk of adverse side-effects to patients, but rather risk of less beneficial outcomes than what can be expected which could change incentives for patients' choice of treatment. This is also related to the extent to which patients might make an autonomous choice, especially taking into account problematic psychological attitudes and biases in medical decision-making. However, the main problem is related to justice and an equitable distribution of scarce health-care resources given the opportunity cost of drugs treatment. When using resources on cancer treatments which later might be found to be less efficacious than was first expected, other patients (in and outside the cancer field) are deprived of potentially more beneficial treatments even though their needs might be equally or more severe. At the same time, demanding more evidence has an ethical cost to patients in terms of depriving them of potential benefits in terms of reduced mortality and morbidity. In order to handle these ethical conflicts further research and analyses are required and it is suggested that pricing strategies and information requirements are alternatives to be further explored

  10. Patient Reported Outcome (PRO) assessment in epilepsy: a review of epilepsy-specific PROs according to the Food and Drug Administration (FDA) regulatory requirements.

    Science.gov (United States)

    Nixon, Annabel; Kerr, Cicely; Breheny, Katie; Wild, Diane

    2013-03-11

    Despite collection of patient reported outcome (PRO) data in clinical trials of antiepileptic drugs (AEDs), PRO results are not being routinely reported on European Medicines Agency (EMA) and Food and Drug Administration (FDA) product labels. This review aimed to evaluate epilepsy-specific PRO instruments against FDA regulatory standards for supporting label claims. Structured literature searches were conducted in Embase and Medline databases to identify epilepsy-specific PRO instruments. Only instruments that could potentially be impacted by pharmacological treatment, were completed by adults and had evidence of some validation work were selected for review. A total of 26 PROs were reviewed based on criteria developed from the FDA regulatory standards. The ability to meet these criteria was classified as either full, partial or no evidence, whereby partial reflected some evidence but not enough to comprehensively address the FDA regulatory standards. Most instruments provided partial evidence of content validity. Input from clinicians and literature was common although few involved patients in both item generation and cognitive debriefing. Construct validity was predominantly compromised by no evidence of a-priori hypotheses of expected relationships. Evidence for test-retest reliability and internal consistency was available for most PROs although few included complete results regarding all subscales and some failed to reach recommended thresholds. The ability to detect change and interpretation of change were not investigated in most instruments and no PROs had published evidence of a conceptual framework. The study concludes that none of the 26 have the full evidence required by the FDA to support a label claim, and all require further research to support their use as an endpoint. The Subjective Handicap of Epilepsy (SHE) and the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) have the fewest gaps that would need to be addressed through

  11. Protecting the public or setting the bar too high? Understanding the causes and consequences of regulatory actions of front-line regulators and specialized drug shop operators in Kenya.

    Science.gov (United States)

    Wafula, Francis; Molyneux, Catherine; Mackintosh, Maureen; Goodman, Catherine

    2013-11-01

    The problem of poor regulatory compliance has been widely reported across private health providers in developing countries. Less known are the underlying reasons for poor compliance, especially with regards to the roles played by front-line regulatory staff, and the regulatory institution as a whole. We designed a qualitative study to address this gap, with the study questions and tools drawing on a conceptual framework informed by theoretical literature on regulation. Data were collected from specialized drug shops (SDSs) in two rural districts in Western Kenya in 2011 through eight focus group discussions, and from regulatory staff from organizations governing the pharmaceutical sector through a total of 24 in-depth interviews. We found that relationships between front-line regulators and SDS operators were a strong influence on regulatory behaviour, often resulting in non-compliance and perverse outcomes such as corruption. It emerged that separate regulatory streams operated in urban and rural locations, based mainly on differing relationships between the front-line regulators and SDS operators, and on broader factors such as the competition environment and community expectations. Effective incentive structures for regulatory staff were either absent, or poorly linked to performance in regulatory organizations, resulting in divergences between the purposes of the regulatory organization and activities of front-line staff. Given the rural-urban differences in the practice environment, the introduction of lower retail practice requirements for rural SDSs could be considered. This would allow illegally operated shops to be brought within the regulatory framework, facilitating good quality provision of essential commodities to marginalized areas, without lowering the practice requirements for the better complying urban SDSs. In addition, regulatory organizations need to devise incentives that better link the level of effort to rewards such as professional

  12. Functional genomics of drug-induced ion homeostasis identifies a novel regulatory crosstalk of iron and zinc regulons in yeast.

    Science.gov (United States)

    Landstetter, Nathalie; Glaser, Walter; Gregori, Christa; Seipelt, Joachim; Kuchler, Karl

    2010-12-01

    Pyrrolidine dithiocarbamate (PDTC), a known inhibitor of NFκB activation, has antioxidative as well as antiviral activities. PDTC is effective against several virus families, indicating that its antiviral mechanism targets host rather than viral functions. To investigate its mode of action, we used baker's yeast as a simple eukaryotic model system and two types of genome-wide analysis. First, expression profiling using whole-genome DNA microarrays identifies more than 200 genes differentially regulated upon PDTC exposure. Interestingly, the Aft1-dependent iron regulon is a main target of PDTC, indicating a lack of iron availability. Moreover, the PDTC-caused zinc influx triggers a strong regulatory effect on zinc transporters due to the cytoplasmic zinc excess. Second, phenotypic screening the EUROSCARF collection for PDTC hypersensitivity identifies numerous mutants implicated in vacuolar maintenance, acidification as well as in transport, mitochondrial organization, and translation. Notably, the screening data indicate significant overlaps of PDTC-sensitive genes and those mediating zinc tolerance. Hence, we show that PDTC induces cytoplasmic zinc excess, eliciting vacuolar detoxification, which in turn, disturbs iron homeostasis and activates the iron-dependent regulator Aft1. Our work reveals a complex crosstalk in yeast ion homeostasis and the underlying regulatory networks.

  13. Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.

    Science.gov (United States)

    Basch, Ethan; Geoghegan, Cindy; Coons, Stephen Joel; Gnanasakthy, Ari; Slagle, Ashley F; Papadopoulos, Elektra J; Kluetz, Paul G

    2015-06-01

    Data reported directly by patients about how they feel and function are rarely included in oncology drug labeling in the United States, in contrast to Europe and to nononcology labeling in the United States, where this practice is more common. Multiple barriers exist, including challenges unique to oncology trials, and industry's concerns regarding cost, logistical complexities, and the Food and Drug Administration's (FDA's) rigorous application of its 2009 guidance on the use of patient-reported outcome (PRO) measures. A panel consisting of representatives of industry, FDA, the PRO Consortium, clinicians, and patients was assembled at a 2014 workshop cosponsored by FDA to identify practical recommendations for overcoming these barriers. Key recommendations included increasing proactive encouragement by FDA to clinical trial sponsors for including PROs in drug development programs; provision of comprehensive PRO plans by sponsors to FDA early in drug development; promotion of an oncology-specific PRO research agenda; development of an approach to existing ("legacy") PRO measures, when appropriate (focused initially on symptoms and functional status); and increased FDA and industry training in PRO methodology. FDA has begun implementing several of these recommendations.

  14. Immune-Regulatory Mechanisms of Classical and Experimental Multiple Sclerosis Drugs: A Special Focus on Helminth-Derived Treatments.

    Science.gov (United States)

    Peón, Alberto N; Terrazas, Luis I

    2016-01-01

    Multiple sclerosis (MS) is the most prevalent autoimmune disease affecting the central nervous system (CNS). Its pathophysiology is centered on neuron myelin sheath destruction in a manner largely dependent upon CD4+/CD8+ T-cell autoreactivity against myelin antigens, inducing Th1/Th17 pathogenic responses with the resulting production of free radicals and soluble mediators that exhibit the effector mechanisms of neurodegeneration. The immune response responsible for this disease is complex and challenges modern medicine. Consequently, many experimental therapies have been proposed in addition to the classical array of immunoregulatory/ immunosuppressive drugs that are normally used to treat MS. In this review, we will describe the effects and mechanisms of action of widely used disease-modifying MS drugs as well as those of select treatments that are currently in the experimental phase. Special emphasis is placed on helminth-derived immunoregulators, as some of them have shown promising results. Additionally, we will compare the mechanisms of action of both the MS drugs and the helminth-derived treatments to discuss the potential importance of some signaling pathways in the control of MS.

  15. Examination of why some community pharmacists do not provide 72-hour emergency prescription drugs to Medicaid patients when prior authorization is not available.

    Science.gov (United States)

    Shepherd, Marvin D

    2013-09-01

    Existing federal law requires that a 72-hour emergency supply of a prescription drug be dispensed to Medicaid patients when prior authorization (PA) is not available and the medication is needed without delay. The pharmacist's role is to contact prescribers and inform them that PA is needed. If the prescriber cannot be reached, the pharmacist can dispense a 72-hour emergency supply. To determine (a) the reasons why some community pharmacy owners/managers, staff pharmacists, and technicians are not compliant with the law; (b) how often the decision is made; and (c) estimate how often pharmacies do not dispense the 72-hour emergency supply when PA is not available. A questionnaire was mailed to selected Texas community pharmacies. The instrument was developed by the researcher and reviewed by the Texas Medicaid Vendor Drug Program staff. The University of Texas, Office of Survey Research collected the data in September and October of 2011 by mail and online. The data were forwarded to the researcher for analyses. A total of 788 identified community pharmacies were mailed a packet containing 3 questionnaires to be completed by the pharmacist-in-charge, a staff pharmacist, and a pharmacy technician. There were 2 mailings of the questionnaire packet and follow-up telephone calls to nonrespondents. A total of 653 questionnaires were completed and returned from 288 community pharmacies (36.7%) out of 788 pharmacies that were mailed the questionnaire packets. A total of 368 (57.5%) completed questionnaires came from chain store pharmacy respondents and 272 (42.5%) questionnaires from independent pharmacy respondents. A total of 21.3% (n = 134) of the respondents indicated that they were not aware of the federal and state requirement to dispense a 72-hour emergency supply of a prescription drug to Medicaid patients when prior authorization (PA) is not available. A greater proportion of the chain store respondents (26.6%) were unaware of the requirement compared with the

  16. Regulatory agencies and regulatory risk

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2007-01-01

    The aim of this paper is to show that regulatory risk is due to the discretionary behaviour of regulatory agencies, caused by a too extensive regulatory mandate provided by the legislator. The normative point of reference and a behavioural model of regulatory agencies based on the positive theory of regulation are presented. Regulatory risk with regard to the future behaviour of regulatory agencies is modelled as the consequence of the ex ante uncertainty about the relative influence of inter...

  17. Drug Authorization for Sofosbuvir/Ledipasvir (Harvoni for Chronic HCV Infection in a Real-World Cohort: A New Barrier in the HCV Care Cascade.

    Directory of Open Access Journals (Sweden)

    Albert Do

    Full Text Available New treatments for hepatitis C (HCV infection hold great promise for cure, but numerous challenges to diagnosing, establishing care, and receiving therapy exist. There are limited data on insurance authorization for these medications.We performed a retrospective chart review of patients receiving sofosbuvir/ledipasvir (SOF/LED from October 11-December 31, 2014 to determine rates and timing of drug authorization. We also determined predictors of approval, and those factors associated with faster decision and approval times.Of 174 patients prescribed HCV therapy during this period, 129 requests were made for SOF/LED, of whom 100 (77.5% received initial approval, and an additional 17 patients (13.9% ultimately received approval through the appeals process. Faster approval times were seen in patients with Child-Pugh Class B disease (14.4 vs. 24.7 days, p = 0.048. A higher proportion of patients were initially approved in those with Medicare/Medicaid coverage (92.2% vs. 71.4%, p = 0.002 and those with baseline viral load ≥ 6 million IU/mL (84.1% vs. 62.5%, p = 0.040. Linear regression modeling identified advanced fibrosis, high Model of End Stage Liver Disease (MELD score, and female gender as significant predictors of shorter decision and approval times. On logistic regression, Medicare/Medicaid coverage (OR 5.96, 95% CI 1.66-21.48 and high viral load (OR 4.52, 95% CI 1.08-19.08 were significant predictors for initial approval.Early analysis of real-world drug authorization outcomes between October-December 2014 reveals that nearly one in four patients are initially denied access to SOF/LED upon initial prescription, although most patients are eventually approved through appeal, which delays treatment initiation. Having Medicare/Medicaid and advanced liver disease resulted in a higher likelihood of approval as well as earlier decision and approval times. More studies are needed to determine factors resulting in higher likelihood of denial and to

  18. Methodological proposal for the construction of the labor profiles of inspectors of the Nuclear Regulatory Authority; Propuesta metodologica para la construccion de los perfiles laborales de inspectores de la Autoridad Regulatoria Nuclear

    Energy Technology Data Exchange (ETDEWEB)

    Larcher, A.M.; Maceiras, E.; Degiovanni, G.; Perrin, C.; Sajaroff, P. [Autoridad Regulatoria Nuclear, Buenos Aires (Argentina)]. e-mail: alarcher@sede.arn.gov.ar

    2006-07-01

    The Argentine Nuclear Regulatory Authority (ARN) like essential part of their strategic institutional plan and in the mark of the modernization of the National Public Administration (NPA), identify the necessity to modify their functional organization, introducing the administration for processes and defining more flexible and better guided structures to the work in team. Starting from the definition of a new institutional flowchart it decided to proceed to a general reorganization of the human resources and on January, 2005 it was prepared the creation of a process whose serious objective to sit down the bases for the development of the professional career of the ARN. To such an end, it was thought about a work outline by stages, the first one of which had as final objective the elaboration of the Labor Profiles of the Institution. The work group for this first stage was integrated by a group of professionals of long trajectory in the institution and not belonging to the sector of Human Resources (RRHH). By this way it was organized as an independent group that it worked in narrow collaboration with the specific sector and informed directly to the maximum institutional direction. For the construction of the profiles a 'mixed' model was chosen that included the requirements of each position (that to make) and the competitions to complete them (how to make it), since a focus purely of competitions has not been seen as the more appropriate for the public administration and in particular for the ARN. In this work it is given to know a part of the results obtained during six months of effective work of the PerLa Group (denominated as well as an acronym of the expression Labor Profiles) putting emphasis in the defined profiles for the inspectors of those different regulatory branches that constitute the environment of competition of the RNA, this is Radiological Protection, Nuclear Safety, Safeguards and Physical Protection. The idea that underlies to the

  19. Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence.

    Science.gov (United States)

    Matsuhama, Maki; Takishita, Tomoko; Kuribayashi, Ryosuke; Takagi, Kazunori; Wakao, Rika; Mikami, Kenichi

    2016-01-01

    A gap analysis survey of international practices for Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) of human use was conducted as a project of the ASMF/DMF working group of the International Generic Drug Regulators Pilot (IGDRP) to identify similarities and differences among ASMF/DMF procedures of 10 IGDRP members and 2 observers. We conducted a questionnaire survey and compared the following aspects: overall ASMF/DMF procedures, submission requirements for ASMFs/DMFs, assessment processes for ASMFs/DMFs, the technical requirements for active pharmaceutical ingredients (APIs), generation of assessment reports for ASMFs/DMFs, procedures for changing ASMF/DMF details, and Good Manufacturing Practice (GMP) inspection/certification of API manufacturers. Twelve organizations participated in this project: the Brazilian Health Surveillance Agency (Anvisa), the European Union (EU), Health Canada (HC), the Singapore Health Sciences Authority (HSA), the South African Medicines Control Council (MCC), the South Korean Ministry of Food and Drug Safety (MFDS), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), the Swiss Agency for Therapeutic Products (Swissmedic), the Taiwan Food and Drug Administration (TFDA), the Australian Therapeutic Goods Administration (TGA), the European Directorate for the Quality of Medicines & HealthCare (EDQM) (Observer) and the Prequalification Team (PQT) of the World Health Organization (WHO), which includes the PQT-Medicines (Observer). Although there were many similarities among the participating agencies surveyed, there were also differences that should be discussed such as assessment processes of ASMFs/DMFs and Technical requirements for APIs. These differences revealed by this survey will be key considerations in order to facilitate the filing of ASMFs/DMFs globally and to establish a framework for sharing and utilizing information related to ASMFs/DMFs among IGDRP members in the future. This article is open to

  20. Author Guidelines

    Directory of Open Access Journals (Sweden)

    Chief Editor

    2016-06-01

    information: Each author's highest academic degrees should be listed, although some journals do not publish these. The name of the department(s and institution(s or organizations where the work should be attributed should be specified. Most electronic submission systems require that authors provide full contact information, including land mail and e-mail addresses, but the title page should list the corresponding authors' telephone and fax numbers and e-mail address. ICMJE encourages the listing of authors’ Open Researcher and Contributor Identification (ORCID. Disclaimers. An example of a disclaimer is an author's statement that the views expressed in the submitted article are his or her own and not an official position of the institution or funder. Source(s of support. These include grants, equipment, drugs, and/or other support that facilitated conduct of the work described in the article or the writing of the article itself. Word count. A word count for the paper's text, excluding its abstract, acknowledgments, tables, figure legends, and references, allows editors and reviewers to assess whether the information contained in the paper warrants the paper's length, and whether the submitted manuscript fits within the journal's formats and word limits. A separate word count for the Abstract is useful for the same reason. Number of figures and tables. Some submission systems require specification of the number of Figures and Tables before uploading the relevant files. These numbers allow editorial staff and reviewers to confirm that all figures and tables were actually included with the manuscript and, because Tables and Figures occupy space, to assess if the information provided by the figures and tables warrants the paper's length and if the manuscript fits within the journal's space limits. Conflict of Interest declaration. Conflict of interest information for each author needs to be part of the manuscript; each journal should develop standards with regard to the

  1. 21 CFR 26.18 - Regulatory collaboration.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Regulatory collaboration. 26.18 Section 26.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL... Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.18 Regulatory...

  2. Author Guidelines

    Directory of Open Access Journals (Sweden)

    Chief Editor

    2015-12-01

    numbers and e-mail address. ICMJE encourages the listing of authors’ Open Researcher and Contributor Identification (ORCID. Disclaimers. An example of a disclaimer is an author's statement that the views expressed in the submitted article are his or her own and not an official position of the institution or funder. Source(s of support. These include grants, equipment, drugs, and/or other support that facilitated conduct of the work described in the article or the writing of the article itself. Word count. A word count for the paper's text, excluding its abstract, acknowledgments, tables, figure legends, and references, allows editors and reviewers to assess whether the information contained in the paper warrants the paper's length, and whether the submitted manuscript fits within the journal's formats and word limits. A separate word count for the Abstract is useful for the same reason. Number of figures and tables. Some submission systems require specification of the number of Figures and Tables before uploading the relevant files. These numbers allow editorial staff and reviewers to confirm that all figures and tables were actually included with the manuscript and, because Tables and Figures occupy space, to assess if the information provided by the figures and tables warrants the paper's length and if the manuscript fits within the journal's space limits. Conflict of Interest declaration. Conflict of interest information for each author needs to be part of the manuscript; each journal should develop standards with regard to the form the information should take and where it will be posted. The ICMJE has developed a uniform conflict of interest disclosure form for use by ICMJE member journals and the ICMJE encourages other journals to adopt it. Despite availability of the form, editors may require conflict of interest declarations on the manuscript title page to save the work of collecting forms from each author prior to making an editorial decision or to save

  3. Internationalization of regulatory requirements.

    Science.gov (United States)

    Juillet, Y

    2003-02-01

    The aim of harmonisation of medicines regulatory requirements is to allow the patient quicker access to new drugs and to avoid animal and human duplications. Harmonisation in the European Union (EU) is now completed, and has led to the submission of one dossier in one language study leading to European marketing authorizations, thanks in particular to efficacy guidelines published at the European level. With the benefit of the European experience since 1989, more than 40 guidelines have been harmonised amongst the EU, Japan and the USA through the International Conference on Harmonisation (ICH). ICH is a unique process gathering regulators and industry experts from the three regions. Its activity is built on expertise and trust. The Common Technical Document (CTD), an agreed common format for application in the three regions, is a logical follow-up to the ICH first phase harmonising the content of the dossier. The CTD final implementation in July 2003 will have considerable influence on the review process and on the exchange of information in the three regions.

  4. 10 CFR 26.57 - Authorization update.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Authorization update. 26.57 Section 26.57 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Granting and Maintaining Authorization § 26.57 Authorization update. (a) Before granting authorization to an individual whose authorization has been interrupted...

  5. Lactobacillus plantarum Strains Can Enhance Human Mucosal and Systemic Immunity and Prevent Non-steroidal Anti-inflammatory Drug Induced Reduction in T Regulatory Cells

    Directory of Open Access Journals (Sweden)

    Paul de Vos

    2017-08-01

    Full Text Available Orally ingested bacteria interact with intestinal mucosa and may impact immunity. However, insights in mechanisms involved are limited. In this randomized placebo-controlled cross-over trial, healthy human subjects were given Lactobacillus plantarum supplementation (strain TIFN101, CIP104448, or WCFS1 or placebo for 7 days. To determine whether L. plantarum can enhance immune response, we compared the effects of three stains on systemic and gut mucosal immunity, by among others assessing memory responses against tetanus toxoid (TT-antigen, and mucosal gene transcription, in human volunteers during induction of mild immune stressor in the intestine, by giving a commonly used enteropathic drug, indomethacin [non-steroidal anti-inflammatory drug (NSAID]. Systemic effects of the interventions were studies in peripheral blood samples. NSAID was found to induce a reduction in serum CD4+/Foxp3 regulatory cells, which was prevented by L. plantarum TIFN101. T-cell polarization experiments showed L. plantarum TIFN101 to enhance responses against TT-antigen, which indicates stimulation of memory responses by this strain. Cell extracts of the specific L. plantarum strains provoked responses after WCFS1 and TIFN101 consumption, indicating stimulation of immune responses against the specific bacteria. Mucosal immunomodulatory effects were studied in duodenal biopsies. In small intestinal mucosa, TIFN101 upregulated genes associated with maintenance of T- and B-cell function and antigen presentation. Furthermore, L. plantarum TIFN101 and WCFS1 downregulated immunological pathways involved in antigen presentation and shared downregulation of snoRNAs, which may suggest cellular destabilization, but may also be an indicator of tissue repair. Full sequencing of the L. plantarum strains revealed possible gene clusters that might be responsible for the differential biological effects of the bacteria on host immunity. In conclusion, the impact of oral consumption L

  6. The Discussion the Approach for Solving the Drug Regulatory Dilemma%浅谈如何破解中国药品监管的困局

    Institute of Scientific and Technical Information of China (English)

    郭萌

    2013-01-01

    近年来,药品安全事故时有发生,药品安监管成为社会大众和学术界非常关心的问题。成立于1998年的国家药监局是国务院机构改革的产物,其在形式上解决了医药领域多头管理、职权交叉、政企不分等问题,并运用行政许可、信息公开等手段对药品安全进行监管,试图达到"以监管为中心,监、帮、促相结合"的政策目标。然而,我国的药品安全问题并未因此得到有效的解决,特别是近期以来,出现了接二连三的药品安全问题及相关案件,这些药品大案要案波及范围极广、影响极坏。药品监管机构职能定位的不准确、机构设置的不合理、制度设计的不完善、决策机制的不科学等因素的综合作用是引发问题的深层次制度性原因。本文共六个部分。引言部分提出了研究问题,第二部分回顾了中国药品安全监管的历史沿革和机构重组,第三部对各国药品监管模式进行比较,第四部对我国药品安全领域的诸多矛盾进行了总结和分析,第五部探讨了引发药品安全问题的社会原因,第六部完善药品监管体制、解决药品安全问题的对策性思考。%In recent years, the drug safety accidents, drug safety supervision management become very concerned about the public. It has been founded in 1998, the State Food and drug administration is a product of the institutional reform of the State Council, which solves the medical field the problem such as authority overlapping, and the use of administrative license, information disclosure and other means to regulate the drug safety, trying to achieve the policy objective-- "in supervision center, supervision, help, promoting the combination". However, it could also be seen that recently various of problems of drug safety and related cases come out, large law cases with big influence happens in succession. The comprehensive ef ect of drug regulators

  7. Post-authorization changes in the safety and efficacy assessment, recommended indications, and drug quality profile of adalimumab: a chronological overview.

    Science.gov (United States)

    Iványi, Gergely; Zelkó, Romána

    2017-02-01

    The intention of the present study was to demonstrate the postauthorization changes of adalimumab (European trade name: Humira), evaluating the variations in its safety, efficacy, and quality profile. Type-II, major variations of the Summary of Product Characteristics (SmPC) from September 8, 2003 to November 19, 2015, were analyzed, which, according to Commission Regulation (EC) No. 1234/2008, have to reflect changes that may have a significant impact on the safety, efficacy, or quality profile of a medicinal product. A unique scoring system was developed to estimate the influence of post-authorization variations in the safety and efficacy assessment, recommended indications, and drug-quality profile of adalimumab. In the past 13 years, adalimumab has been proven to be beneficial in 12 indications. In this time period, the safety-related subsections of the SmPC expanded the most. 27.12% of the total changes were found in subsection 4.8 (Undesirable effects), 19.77% in subsection 4.4 (Special warnings and precautions for use). Section 5 (Pharmacological properties) was also significantly modified (19.77%) thanks to the numerous clinical trials studying the effects of adalimumab. Concerning the total changes in the content of the SmPC, 58.4% was safety, 29.4% efficacy, and only 1.8% was quality-related alteration. The rest, 10.4%, was considered as administrational modification. The extensive postauthorization research (both surveillance and clinical trials) significantly have increased our knowledge about the efficient and safe use of the medicine and have made adalimumab one of the top-10 selling pharmaceuticals worldwide. Regarding ongoing clinical trials, more pediatric indications are expected.

  8. 78 FR 62345 - Sabine River Authority of Texas; Sabine River Authority, State of Louisiana; Notice of...

    Science.gov (United States)

    2013-10-18

    ... Energy Regulatory Commission Sabine River Authority of Texas; Sabine River Authority, State of Louisiana; Notice of Authorization for Continued Project Operation On September 30 2011, the Sabine River Authority of Texas and Sabine River Authority, State of Louisiana (Sabine River Authorities), licensee(s)...

  9. Rol del estado como autoridad reguladora de ensayos clínicos en el Perú Role of the state as regulatory authority of clinical trials in Peru

    Directory of Open Access Journals (Sweden)

    Duilio Fuentes

    2012-12-01

    Full Text Available El artículo hace una revisión histórica del proceso regulatorio de ensayos clínicos hasta llegar a la publicación del Reglamento de ensayos clínicos en el Perú, mediante Decreto Supremo 017-2006-SA. En menos de un año se modificó parte del Reglamento, teniendo muchas críticas entre ellas las de la Defensoría del Pueblo. Por otra parte, se hace un recuento de los logros como autoridad reguladora que han fortalecido su rol rector y su principal objetivo de protección de los derechos, seguridad y bienestar de los participantes en ensayos clínicos. Estos logros son los siguientes: el registro interno de ensayos clínicos, fortalecimiento de las inspecciones a todos los actores de la investigación, el sistema de notificación de eventos adversos serios (REAS-NET, la publicación de la Guía de aspectos éticos, legales y metodológicos de los ensayos clínicos para su uso por los comités de ética, que mereció un premio internacional, el primer puesto en la categoría de Fiscalización y cumplimiento de la ley, por la buena práctica de gestión pública: “Protegiendo los derechos de las personas participantes en estudios experimentales”, la publicación del nuevo Manual de procedimientos de ensayos clínicos y el Plan de implementación de la Red Nacional de Bioética en el Perú.This article sheds the light on historical review of the clinical trials regulatory process to the publication of the Clinical Trials Regulation in Peru, by Supreme Decree 017-2006-SA. In this context, that Regulation was amended within one year, with many critics including from the Ombudsman. It also considers the achievements as a regulatory authority that has strengthened its steering and its main objective of protecting the rights, safety and welfare of human subjects in clinical trials. Those achievements are: the internal register of clinical trials, strengthening inspections on all stakeholders that take part in research, the Notification System

  10. Decisions in drug adverse reactions, intoxications and unexpected responses to herbal medicines as public health problems

    OpenAIRE

    Álvarez-Falconí, Pedro P.; Médico Farmacólogo, Bachiller en Derecho, Doctor en Medicina. Centro Nacional de Salud Pública, Instituto Nacional de Salud. Lima, Perú. Laboratorio de Investigación en Plantas Medicinales, Instituto Nacional de Salud. Lima, Perú.

    2007-01-01

    This review evaluates the relevant information on a variety of adverse drug reactions serious, real or potential, attributed to some drugs relatively recent introduction into the world market, in addition, on some intoxications by contaminated medicines, all of which contributed to decision-making in the past and present, by regulatory authorities in drugs in several countries. It explores the broad strategies related to the pillars of the drug policies, the historical and current events ...

  11. 21 CFR 500.88 - Regulatory method.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b)...

  12. Defining Tobacco Regulatory Science Competencies.

    Science.gov (United States)

    Wipfli, Heather L; Berman, Micah; Hanson, Kacey; Kelder, Steven; Solis, Amy; Villanti, Andrea C; Ribeiro, Carla M P; Meissner, Helen I; Anderson, Roger

    2017-02-01

    In 2013, the National Institutes of Health and the Food and Drug Administration funded a network of 14 Tobacco Centers of Regulatory Science (TCORS) with a mission that included research and training. A cross-TCORS Panel was established to define tobacco regulatory science (TRS) competencies to help harmonize and guide their emerging educational programs. The purpose of this paper is to describe the Panel's work to develop core TRS domains and competencies. The Panel developed the list of domains and competencies using a semistructured Delphi method divided into four phases occurring between November 2013 and August 2015. The final proposed list included a total of 51 competencies across six core domains and 28 competencies across five specialized domains. There is a need for continued discussion to establish the utility of the proposed set of competencies for emerging TRS curricula and to identify the best strategies for incorporating these competencies into TRS training programs. Given the field's broad multidisciplinary nature, further experience is needed to refine the core domains that should be covered in TRS training programs versus knowledge obtained in more specialized programs. Regulatory science to inform the regulation of tobacco products is an emerging field. The paper provides an initial list of core and specialized domains and competencies to be used in developing curricula for new and emerging training programs aimed at preparing a new cohort of scientists to conduct critical TRS research. © The Author 2016. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  13. Relfection on Drug Regulatory Globalization Trend from the Heparin Sodium Event%由肝素钠事件分析药品监管全球化趋势

    Institute of Scientific and Technical Information of China (English)

    田德龙; 黄志禄

    2016-01-01

    Objective To provide some suggestions to cope with the challenges of drug regulatory globalization.Methods The investigation to the reason of event inspection, communication, rehabilitation and the deep risk of supply chain were analyzed through reviewing measures that FDA and relevant parties had given to heparin sodium event.Results Drug regulatory globalization is essentially the globalization of raw materials, intermediate products and preparations supply chain.Conclusion FDA’s global drug regulation has provided referential experience to China, and China should comply with the trend of regulatory globalization and take active countermeasures to ensure the safety of the drug supply chain.%目的:为我国应对药品监管全球化挑战提供参考。方法通过剖析肝素钠事件中美国FDA、涉事企业及相关各方应对过程,分析事件原因调查、检验、沟通、善后措施以及深层次供应链风险。结果药品监管全球化实质是原辅料、中间产品、制剂供应链的全球化。结论我国应借鉴美国药品全球化监管经验,顺应监管全球化趋势,采取积极应对措施以确保药品供应链安全。

  14. Rationales for regulatory activity

    Energy Technology Data Exchange (ETDEWEB)

    Perhac, R.M. [Univ. of Tennessee, Knoxville, TN (United States)

    1997-02-01

    The author provides an outline which touches on the types of concerns about risk evaluation which are addressed in the process of establishing regulatory guides. Broadly he says regulatory activity serves three broad constituents: (1) Paternalism (private risk); (2) Promotion of social welfare (public risks); (3) Protection of individual rights (public risks). He then discusses some of the major issues encountered in reaching a decision on what is an acceptable level of risk within each of these areas, and how one establishes such a level.

  15. Author Details

    African Journals Online (AJOL)

    Journal Home > Advanced Search > Author Details ... Intra‑Operative Airway Management in Patients with Maxillofacial Trauma having Reduction and ... Clinical Parameters and Challenges of Managing Cervicofacial Necrotizing Fasciitis in a ...

  16. Author Details

    African Journals Online (AJOL)

    Journal Home > Advanced Search > Author Details. Log in or ... Difficult airway management in a patient with giant malignant goitre scheduled for thyroidectomy - case report ... Airway Management Dilemma in a Patient with Maxillofacial Injury

  17. Author Details

    African Journals Online (AJOL)

    Journal Home > Advanced Search > Author Details ... Sequencing for Batch Production in a Group Flowline Machine Shop ... Sampling Plans for Monitoring Quality Control Process at a Plastic Manufacturing Firm in Nigeria: A Case Study

  18. Should health authorities offer risk-sharing contracts to pharmaceutical firms? A theoretical approach.

    Science.gov (United States)

    Antonanzas, Fernando; Juarez-Castello, Carmelo; Rodriguez-Ibeas, Roberto

    2011-07-01

    In this paper, we characterise the risk-sharing contracts that health authorities can design when they face a regulatory decision on drug pricing and reimbursement in a context of uncertainty. We focus on two types of contracts. On the one hand, the health authority can reimburse the firm for each treated patient regardless of health outcomes (non risk-sharing). Alternatively, the health authority can pay for the drug only when the patient is cured (risk-sharing contract). The optimal contract depends on the trade-off between the monitoring costs, the marginal production cost and the utility derived from treatment. A non-risk-sharing agreement will be preferred by the health authority, if patients who should not be treated impose a relatively low cost to the health system. When this cost is high, the health authority would prefer a risk-sharing agreement for relatively low monitoring costs.

  19. Author Guidelines

    OpenAIRE

    Istadi Istadi

    2011-01-01

    AUTHOR GUIDELINES Indian Journal of Community Health (IJCH) accepts only online submission of manuscript(s) by using Open Journal software (OJS) at http://www.iapsmupuk.org/journal/index.php/IJCH/login Online SubmissionsAlready have a Username/Password for Indian Journal of Community Health (IJCH)? GO TO LOGINNeed a Username/Password?GO TO REGISTRATIONNote: Registration and login are required to submit items online and to track the status of current submissions.Author GuidelinesIJCH strictly ...

  20. [Annual review of serotypes of E. coli isolated from various lesions in poultry and their sensitivity to drugs in vitro (author's transl)].

    Science.gov (United States)

    Goren, E

    1976-05-15

    550 Strains of E. coli, isolated from poultry, were typed. In addition, their sensitivity to various drugs was tested. A wide variety of serotypes was found to be present. Approximately 50% of the isolated strains of E. coli were found to be resistant to the tetracyclines, streptomycin and sulphafurazole. Chloramphenicol, neomycin and furazolidone usually were effective.

  1. Key opinion leaders: used as a marketing tool by drug companies.

    Science.gov (United States)

    2012-06-01

    In marketing, "key opinion leaders" are used to influence purchasing behaviour through their perceived position of authority. In drug marketing, key opinion leaders are renowned physicians and other healthcare professionals on whom the medical profession rely when forming an opinion on a drug or practice. Pharmaceutical companies use key opinion leaders as marketing tools to promote their drugs or influence the decisions of regulatory agencies and other institutions. Opinion leaders are carefully handled and their management is often outsourced to specialised marketing agencies.

  2. Fatal adverse drug reactions of anticancer drugs detected by all-case post-marketing surveillance in Japan.

    Science.gov (United States)

    Mori, Jinichi; Tanimoto, Tetsuya; Miura, Yuji; Kami, Masahiro

    2015-06-01

    All-case post-marketing surveillance of newly approved anticancer drugs is usually conducted on all patients in Japan. The present study investigates whether all-case post-marketing surveillance identifies fatal adverse drug reactions undetected before market entry. We examined fatal adverse drug reactions identified via all-case post-marketing surveillance by reviewing the disclosed post-marketing surveillance results, and determined the time points in which the fatal adverse drug reactions were initially reported by reviewing drug labels. We additionally scanned emergency alerts on the Japanese regulatory authority website to assess the relationship between all-case post-marketing surveillance and regulatory action. Twenty-five all-case post-marketing surveillances were performed between January 1999 and December 2009. Eight all-case post-marketing surveillances with final results included information on all fatal cases. Of these, the median number of patients was 1287 (range: 106-4998), the median number of fatal adverse drug reactions was 14.5 (range: 4-23). Of the 111 fatal adverse drug reactions detected in the eight post-marketing surveillances, only 28 (25.0%) and 22 (19.6%) were described on the initial global and the initial Japanese drug label, respectively, and 58 (52.3%) fatal adverse drug reactions were first described in the all-case post-marketing surveillance reports. Despite this, the regulatory authority issued only four warning letters, and two of these were prompted by case reports from the all-case post-marketing surveillance. All-case post-marketing surveillance of newly approved anticancer drugs in Japan was useful for the rigorous compilation of non-specific adverse drug reactions, but it rarely detected clinically significant fatal adverse drug reactions. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  3. AUTHOR GUIDELINES

    Directory of Open Access Journals (Sweden)

    Chief Editor

    2014-12-01

    Full Text Available AUTHOR GUIDELINESIndian Journal of Community Health (IJCH accepts only online submission of manuscript(s by using Open Journal software (OJS at http://www.iapsmupuk.org/journal/index.php/IJCH/loginOnline SubmissionsAlready have a Username/Password for Indian Journal of Community Health (IJCH? GO TO LOGINNeed a Username/Password?GO TO REGISTRATIONNote: Registration and login are required to submit items online and to track the status of current submissions.Author GuidelinesIJCH strictly adheres on the recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals as per the standard universal guidelines given by International Committee of Medical Journal Editors (ICMJE - Recommendations for Uniform Requirements for Manuscripts. Authors are requested to visit http://www.icmje.org/index.html before making online submission of their manuscript(s.SectionsEditorial:On issues of current public health needAbout 1000 – 1200 wordsReferences: 5 – 10 (PubMed - Citation preferredInvited Commentary:Brief, provocative, opinionated communicationsOn issues of current public health needMain Text: 750-1000 words excluding referencesReferences: 5 – 10 (PubMed - Citation preferredOriginal Article:Articles from Original ResearchStructured abstract: 250 wordsMain Text: 2500 - 3000 words, IMRD formatKey Words: 5 - 8References: 20 – 25 (PubMed - Citation preferredTables / Figures: 3 – 4*Certificate of clearance from respective Institutional Ethical Committee (IECReview Article:On subject of public health relevanceAbstract: 250 wordsMain Text: 2500 - 3000 wordsKey Words: 3 - 4References: 20 – 25 (PubMed - Citation preferredTables / Figures: 3 – 4Short Communication / Article:Short report of a research project / outbreakMain Text : 1000 – 1200 wordsReferences: 10 – 15 (PubMed - Citation preferredTable / Figure: 01*Certificate of clearance from respective Institutional Ethical Committee (IECReport from the field

  4. Regulatory Anatomy

    DEFF Research Database (Denmark)

    Hoeyer, Klaus

    2015-01-01

    This article proposes the term “safety logics” to understand attempts within the European Union (EU) to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, le...... they arise. In short, I expose the regulatory anatomy of the policy landscape....

  5. 重构我国互联网药品经营监管制度--经验、挑战和对策%Online Drug Sale Regulatory Institution Reconstruction -- Experience, Challenge and Recommendation

    Institute of Scientific and Technical Information of China (English)

    胡颖廉

    2014-01-01

    Online drug sale occurred at the middle of 1990s, forming three regulatory models, namely, pluralism, corporatism and statism, in other countries. While in China, there are three main business types, including third-party e-commerce platform, B2B and B2C, with some other new types emerging. However, online drug regulation and relevant safety record are not optimistic. The current regulation has four defects, which are low legislative order, lack of core content, mixed legal subjects and single enforcement measure. Online drug sale can be neither completely opened nor banned, but to take a compromised regulation path. Therefore, it is suggested that in this chance of the Drug Administration Law amendment as well as the implementation of third-party e-commerce platform of online drug sale, the positioning, ideology, path and means of China’s online drug sale regulatory institution should be reconstructed.%互联网药品经营出现于上世纪末,国外形成了多元主义、法团主义和国家主义三类监管模式。我国目前有第三方、B2B、B2C等经营类型,新业态不断涌现,然而安全状况不容乐观。现有监管制度存在立法位阶偏低、内容缺失、主体混杂和手段单一等问题。完全放开或彻底禁止互联网药品经营都不符合实际,应采取折衷的互联网药品经营监管模式。建议利用修订《药品管理法》和开展互联网药品经营第三方电子商务平台试点的契机,重构我国互联网药品监管制度的定位、理念、路径和手段。

  6. 76 FR 66089 - Access Authorization Program for Nuclear Power Plants

    Science.gov (United States)

    2011-10-25

    ... COMMISSION Access Authorization Program for Nuclear Power Plants AGENCY: Nuclear Regulatory Commission... revision to Regulatory Guide 5.66, ``Access Authorization Program for Nuclear Power Plants.'' This guide... Authorization Requirements for Nuclear Power Plants,'' and 10 CFR part 26, ``Fitness for Duty Programs.'' The......

  7. Off-Label Drug Use in Pediatric Practice: Unsolved Problems

    Directory of Open Access Journals (Sweden)

    A. R. Titova

    2015-01-01

    Full Text Available The widespread «off-label» drug use and the prescribing of unlicensed medicines in pediatric practice is a major health problem. The authors discuss actual regulatory and legal issues of «off-label» drug use in children in the US, Europe and Russia. The results of different population-based studies from many countries, showing the structure and frequency of «off-label» drug use in children, are summarized in this article. It is shown that such practice increases the risk of adverse drug reactions. The authors offer practical recommendations for a safer use of drugs in pediatric practice. The priority issue is conducting high quality clinical trials with the participation of children, improving national pharmacovigilance and the monitoring of off-label drug use, developing pediatric formularies, improving doctors’ knowledge and awareness of safety and efficacy of medicines in pediatric population.

  8. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma.

    Science.gov (United States)

    Eichler, Hans-Georg; Pignatti, Francesco; Flamion, Bruno; Leufkens, Hubert; Breckenridge, Alasdair

    2008-10-01

    Drug regulatory agencies are increasingly pressed by the challenge of finding the appropriate balance between the need for rapid access to new drugs and the need to ensure comprehensive data on their benefits and risks. This dilemma is not new, but has been made more prominent by recent high-profile drug withdrawals and conflicting demands, including the need to improve the efficiency of drug development on one hand, and the need to avoid exposing patients to unnecessary risks or possibly ineffective treatments on the other. Here, we summarize the current demands by stakeholders and the scientific and regulatory issues at stake, describe existing and emerging regulatory approaches, and speculate on future directions, such as evolution of the current regulatory model from a one-off marketing authorization to a life-cycle approach.

  9. Author Guidelines

    Directory of Open Access Journals (Sweden)

    Yunisrina Qismullah Yusuf

    2015-10-01

    Full Text Available Guidelines for Article Submission SiELE journal accepts articles on research and development in the field of teaching and learning of English, linguistics, educational development, policy and cultural studies in education.To be considered for publication, the article should be presented in the following system:First page: include a title page with the full title of the paper (must not exceed 16 words, the author(s’ name(s, affiliation(s, phone number(s and e-mail address of the corresponding author. A brief bio-data of the author(s (maximum of 100 words is provided in this page.Second page and subsequent page: Submissions should be between 4000-6000 (including abstract, table(s, figure(s and references in A4 size paper with margins as the following: top 3 cm, bottom 3 cm, right 2.5 cm and left 4 cm. The font is Times New Roman, size 12 and single spaced. The article should generally consist of the following sections: introduction, review of literature, method, findings, discussion and conclusion.Headings and subheadings should be presented as follows (provide a space between the headings and sub-headings. 1         INTRODUCTION1.1      Subheading of the Content 1.1.1   Subheading of the Content  For Tables, the title size is 12 and the content size is 10. Please number the tables subsequently throughout your article and the title is written above the table.For Figures, the title size is 12 and the content size (if any is 10. Please number the figures subsequently throughout your article and the title is written below the figure.The reference list should be arranged alphabetically following the guidelines of the Publication Manual of the American Psychological Association (5th ed.. See the following examples: Book: Ellis, R. (2003. Task-based language learning and teaching. Oxford: Oxford University Press.Internet source: Andrewes, S. (2003. Group work v. whole-class activities. Retrieved October 1, 2012 from http://www

  10. Author Guidelines

    Directory of Open Access Journals (Sweden)

    Yunisrina Qismullah Yusuf

    2014-03-01

    Full Text Available Guidelines for Article Submission SiELE journal accepts articles on research and development in the field of teaching and learning of English, linguistics, educational development, policy and cultural studies in education.To be considered for publication, the article should be presented in the following system:First page: include a title page with the full title of the paper (must not exceed 16 words, the author(s’ name(s, affiliation(s, phone number(s and e-mail address of the corresponding author. A brief bio-data of the author(s (maximum of 100 words is provided in this page.Second page and subsequent page: Submissions should be between 4000-6000 (including abstract, table(s, figure(s and references in A4 size paper with margins as the following: top 3 cm, bottom 3 cm, right 2.5 cm and left 4 cm. The font is Times New Roman, size 12 and single spaced. The article should generally consist of the following sections: introduction, review of literature, method, findings, discussion and conclusion.Headings and subheadings should be presented as follows (provide a space between the headings and sub-headings. 1         INTRODUCTION1.1      Subheading of the content 1.1.1   Subheading of the content  For Tables, the title size is 12 and the content size is 10. Please number the tables subsequently throughout your article and the title is written above the table.For Figures, the title size is 12 and the content size (if any is 10. Please number the figures subsequently throughout your article and the title is written below the figure.The reference list should be arranged alphabetically following the guidelines of the Publication Manual of the American Psychological Association (5th ed.. See the following examples: Book: Ellis, R. (2003. Task-based language learning and teaching. Oxford: Oxford University Press.Internet source: Andrewes, S. (2003. Group work v. whole-class activities. Retrieved October 1, 2012 from http://www

  11. Author Guidelines

    Directory of Open Access Journals (Sweden)

    Yunisrina Qismullah Yusuf

    2014-09-01

    Full Text Available Guidelines for Article Submission SiELE journal accepts articles on research and development in the field of teaching and learning of English, linguistics, educational development, policy and cultural studies in education.To be considered for publication, the article should be presented in the following system:First page: include a title page with the full title of the paper (must not exceed 16 words, the author(s’ name(s, affiliation(s, phone number(s and e-mail address of the corresponding author. A brief bio-data of the author(s (maximum of 100 words is provided in this page.Second page and subsequent page: Submissions should be between 4000-6000 (including abstract, table(s, figure(s and references in A4 size paper with margins as the following: top 3 cm, bottom 3 cm, right 2.5 cm and left 4 cm. The font is Times New Roman, size 12 and single spaced. The article should generally consist of the following sections: introduction, review of literature, method, findings, discussion and conclusion.Headings and subheadings should be presented as follows (provide a space between the headings and sub-headings. 1         INTRODUCTION1.1      Subheading of the content 1.1.1   Subheading of the content  For Tables, the title size is 12 and the content size is 10. Please number the tables subsequently throughout your article and the title is written above the table.For Figures, the title size is 12 and the content size (if any is 10. Please number the figures subsequently throughout your article and the title is written below the figure.The reference list should be arranged alphabetically following the guidelines of the Publication Manual of the American Psychological Association (5th ed.. See the following examples: Book: Ellis, R. (2003. Task-based language learning and teaching. Oxford: Oxford University Press.Internet source: Andrewes, S. (2003. Group work v. whole-class activities. Retrieved October 1, 2012 from http://www

  12. Author Guidelines

    Directory of Open Access Journals (Sweden)

    Yunisrina Qismullah Yusuf

    2016-03-01

    Full Text Available Guidelines for Article Submission SiELE journal accepts articles on research and development in the field of teaching and learning of English, linguistics, educational development, policy and cultural studies in education. To be considered for publication, the article should be presented in the following system: First page: include a title page with the full title of the paper (must not exceed 16 words, the author(s’ name(s, affiliation(s, phone number(s and e-mail address of the corresponding author. A brief bio-data of the author(s (maximum of 100 words is provided in this page. Second p age and subsequent page: Submissions should be between 4000-6000 (including abstract, table(s, figure(s and references in A4 size paper with margins as the following: top 3 cm, bottom 3 cm, right 2.5 cm and left 4 cm. The font is Times New Roman, size 12 and single spaced. The article should generally consist of the following sections: introduction, review of literature, method, findings, discussion and conclusion. Headings and subheadings should be presented as follows (provide a space between the headings and sub-headings. 1 INTRODUCTION 1.1 Subheading of the Content 1.1.1 Subheading of the Content For Tables, the title size is 12 and the content size is 10. Please number the tables subsequently throughout your article and the title is written above the table. For Figures, the title size is 12 and the content size (if any is 10. Please number the figures subsequently throughout your article and the title is written below the figure. The reference list should be arranged alphabetically following the guidelines of the Publication Manual of the American Psychological Association (5th ed.. See the following examples:   Book: Ellis, R. (2003. Task-based language learning and teaching. Oxford: Oxford University Press. Internet source: Andrewes, S. (2003. Group work v. whole-class activities. Retrieved October 1, 2012 from http://www.teachingenglish.org

  13. Author Guidelines

    Directory of Open Access Journals (Sweden)

    Yunisrina Qismullah Yusuf

    2015-03-01

    Full Text Available Guidelines for Article Submission SiELE journal accepts articles on research and development in the field of teaching and learning of English, linguistics, educational development, policy and cultural studies in education. To be considered for publication, the article should be presented in the following system: First page: include a title page with the full title of the paper (must not exceed 16 words, the author(s’ name(s, affiliation(s, phone number(s and e-mail address of the corresponding author. A brief bio-data of the author(s (maximum of 100 words is provided in this page. Second page and subsequent page: Submissions should be between 4000-6000 (including abstract, table(s, figure(s and references in A4 size paper with margins as the following: top 3 cm, bottom 3 cm, right 2.5 cm and left 4 cm. The font is Times New Roman, size 12 and single spaced. The article should generally consist of the following sections: introduction, review of literature, method, findings, discussion and conclusion. Headings and subheadings should be presented as follows (provide a space between the headings and sub-headings. 1 INTRODUCTION 1.1 Subheading of the content 1.1.1 Subheading of the content For Tables, the title size is 12 and the content size is 10. Please number the tables subsequently throughout your article and the title is written above the table. For Figures, the title size is 12 and the content size (if any is 10. Please number the figures subsequently throughout your article and the title is written below the figure. The reference list should be arranged alphabetically following the guidelines of the Publication Manual of the American Psychological Association (5th ed.. See the following examples: Back Matter| 79 80 | STUDIES IN ENGLISH LANGUAGE AND EDUCATION, Volume 1, Number 1, March 2014 Book: Ellis, R. (2003. Task-based language learning and teaching. Oxford: Oxford University Press. Internet source: Andrewes, S. (2003. Group work v

  14. International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences

    OpenAIRE

    Lu, Dongmei; Lee, Sau L.; Lionberger, Robert A.; Choi, Stephanie; Adams, Wallace; Caramenico, Hoainhon N.; Chowdhury, Badrul A.; Conner, Dale P.; Katial, Rohit; Limb, Susan; Peters, John R.; Yu, Lawrence; Seymour, Sally; Li, Bing V.

    2015-01-01

    International regulatory agencies have developed recommendations and guidances for bioequivalence approaches of orally inhaled drug products (OIDPs) for local action. The objective of this article is to discuss the similarities and differences among these approaches used by international regulatory authorities when applications of generic and/or subsequent entry locally acting OIDPs are evaluated. We focused on four jurisdictions that currently have published related guidances for generic and...

  15. 76 FR 48169 - Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...

    Science.gov (United States)

    2011-08-08

    ... following public meeting: ``Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical... microbiology/MCM devices. The ultimate goal is to advance regulatory science for highly multiplexed devices... HUMAN SERVICES Food and Drug Administration Advancing Regulatory Science for Highly...

  16. 76 FR 71982 - Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...

    Science.gov (United States)

    2011-11-21

    ... paper entitled ''Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure... the ``Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices... HUMAN SERVICES Food and Drug Administration Advancing Regulatory Science for Highly...

  17. Drug-induced liver injury and drug development: industry perspective.

    Science.gov (United States)

    Regev, Arie

    2014-05-01

    Despite intensive ongoing research, drug-induced live injury (DILI) remains a serious issue for care providers and patients, and has been a major cause of drug withdrawal and non-approval by regulatory authorities in the past 50 years. Consequently, DILI remains a major concern for the pharmaceutical industry and a leading cause for attrition during drug development. In most instances, severe DILI is an uncommon idiosyncratic reaction, which typically does not present during preclinical phases or early clinical phases of drug development. In the majority of cases, drugs that caused severe DILI in humans have not shown clear and consistent hepatotoxic signals in preclinical assessment including animal studies, cell cultures, or other methods. Despite intensive efforts to develop better biomarkers that would help in predicting DILI risk in earlier phases of drug development, such biomarkers are currently not supported by sufficient evidence and are not yet available for routine use by drug makers. Due to the lack of effective and accurate methods for prediction of idiosyncratic DILI during preclinical phases of drug development, different drug makers have adopted different approaches, which are often not supported by strong systematic evidence. Based on growing experience, it is becoming increasingly evident that milder forms of liver injury occurring during clinical development, when assessed correctly, may significantly enhance our ability to predict the drug's potential to cause more severe liver injury postmarketing. Strategies based on this concept have been adopted by many drug makers, and are being increasingly implemented during drug development. Meticulous causality assessment of individual hepatic cases and adherence to strict hepatic discontinuation rules are critical components of this approach and have to rely on thorough clinical evaluation and occasionally on assessment by liver experts experienced with DILI and drug development.

  18. Variation in adverse drug reactions listed in product information for antidepressants and anticonvulsants, between the USA and Europe: a comparison review of paired regulatory documents.

    Science.gov (United States)

    Cornelius, Victoria R; Liu, Kun; Peacock, Janet; Sauzet, Odile

    2016-03-20

    To compare consistency of adverse drug reaction (ADR) data in publicly available product information documents for brand drugs, between the USA and Europe. To assess the usefulness of information for prescribers and patients. A comparison review of product information documents for antidepressants and anticonvulsants concurrently marketed by the same pharmaceutical company in the USA and Europe. For each drug, data were extracted from the US Product Inserts and the European Summary of Product Characteristics documents between 09/2013 and 01/2015. Individuals contributing ADR information to product information documents. All ADRs reported in product information sections 5 and 6 (USA), and 4·4 and 4·8 (Europe). Twelve brand drugs--24 paired documents--were included. On average, there were 77 more ADRs reported in the USA compared with in the European product information document, with a median number of 201 ADRs (range: 65-425) and 114 (range: 56-265), respectively. More product information documents in the USA reported information on the source of evidence (10 vs 5) and risk (9 vs 5) for greater than 80% of ADRs included in the document. There was negligible information included regarding duration, severity, reversibility or recurrence of ADRs. On average, only 29% of ADR terms were reported in both paired documents. Product information documents contained a large number of ADRs, but lacked contextual data and information important to patients and prescribers, such as duration, severity and reversibility. The ADR profile was found to be inconsistently reported between the USA and Europe, for the same drug. Identifying, selecting, summarising and presenting multidimensional harm data should be underpinned by practical evidence-based guidelines. In order for prescribers to provide considered risk-benefit advice across competing drug therapies to patients, they need access to comprehensible and reliable ADR information. Published by the BMJ Publishing Group Limited

  19. A look backward and forward in the regulatory and treatment history of multiple myeloma: Approval of novel-novel agents, new drug development, and longer patient survival.

    Science.gov (United States)

    Kazandjian, Dickran; Landgren, Ola

    2016-12-01

    The past decade has seen significant advances in our understanding and treatment of multiple myeloma (MM) and its precursor diseases. These advances include gains in knowledge of the underlying pathobiology including molecular and cellular prognostic factors for disease progression. In parallel we have witnessed the availability of novel therapeutics. Together these advances have translated into improvements in long-term clinical benefit and survival in MM. Indeed, it has been shown that patients diagnosed in the last decade have experienced almost doubling of median survival time. We aim to review and give further insight into drug development and novel drug approvals that have revolutionized the treatment of MM.

  20. Legal principles of regulatory administration and nuclear safety regulation

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Kyeong Hui; Cheong, Sang Kee [Hannam Univ., Taejon (Korea, Republic of)

    2000-12-15

    This research presents a critical analysis and evaluation of principles of administrative laws in order to provide framework of structural reform on the nuclear safety regulation system. The focus of this analysis and evaluation is centered around the area of origin of regulatory administrative laws; authorities of regulation; procedures of regulatory actions; regulatory enforcement; and administrative relief system. In chapter 2 the concept of regulatory administration is analysed. Chapter 3 identifies the origin of regulatory administration and the principles of administration laws. It also examines legal nature of the nuclear safety standard. In relation to regulatory authorities. Chapter 4 identifies role and responsibility of administration authorities and institutions. It also examines fundamental principles of delegation of power. Then the chapter discusses the nuclear safety regulation authorities and their roles and responsibilities. Chapter 5 classifies and examines regulatory administration actions. Chapter 6 evaluates enforcement measure for effectiveness of regulation. Finally, chapter 7 discusses the administrative relief system for reviewing unreasonable regulatory acts.

  1. Fractal analysis as a complementary approach to predict the stability of drug delivery nano systems in aqueous and biological media: a regulatory proposal or a dream?

    Science.gov (United States)

    Demetzos, Costas; Pippa, Natassa

    2014-10-01

    The morphology of drug nanocarriers correlates with their functionality, which is mainly shuttled on their surface where most of the interactions and interfacial phenomena occur. The quantification of their morphological fingerprint requires an analytical tool that should be established based on experimental data and can be correlated with their stability. The morphological quantification picture of the advanced Drug Delivery nano Systems (aDDnSs) could be achieved via fractal analysis and by introducing a novel proposed parameter, defined as ωD. This parameter is based on mathematical limits determined experimentally and on already existing theories on the colloidal fractal aggregation process which can correlate the morphological characteristics of aDDnSs with their physicochemical stability in aqueous and biological media. This review article proposes the fractal analysis and the ωD as an analytical tool and prediction parameter, respectively, which are able to promote an attractive and alternative path for studying drug delivery nanocarriers. Moreover, these approaches could facilitate the scale up process of pharmaceutical industry, and could shed more light in the quantification of drug delivery nanosystems.

  2. Health status of users of the Bologna local health authority drug addiction treatment services: a study of hospital admissions in the period 2004-2013.

    Science.gov (United States)

    Pavarin, Raimondo Maria; Gambini, Daniele

    2015-03-01

    The aim of this study was to monitor the health status of the users of the services for drug addiction (SERT) in the metropolitan area of Bologna by analysing the hospital discharge records (SDO). For the period 2004-2013, among the residents of the metropolitan areas aged 15-64, we compared the trend in hospital admissions of SERT users with that of the general population. We calculated the standardised rates of hospitalisation and the likelihood of admission. Over the period in question the standardised hospitalisation rates decreased, with a larger drop among SERT users (330.17 males per 10,000 inhabitants in 2004, 215.91 in 2013; 547.60 females per 10,000 inhabitants in 2004, 283.20 in 2013) as compared with the general population (109.49 males in 2004, 82.16 in 2013; 161.40 females in 2004, 124.38 in 2013). Admission likelihood was always higher for SERT users, but was lower in 2013 than in 2004, especially for infectious diseases and psychic disorders. The results highlight the effectiveness of Bologna's local system of services in taking care of aspects connected to addiction, as well as health-related disorders.

  3. Authorization and Toxicity of Veterinary Drugs and Plant Protection Products: Residues of the Active Ingredients in Food and Feed and Toxicity Problems Related to Adjuvants

    Directory of Open Access Journals (Sweden)

    Szandra Klátyik

    2017-09-01

    Full Text Available Chemical substances applied in animal husbandry or veterinary medicine and in crop protection represent substantial environmental loads, and their residues occur in food and feed products. Product approval is governed differently in these two sectors in the European Union (EU, and the occurrence of veterinary drug (VD and pesticide residues indicated by contamination notification cases in the Rapid Alert System for Food and Feed of the EU also show characteristic differences. While the initial high numbers of VD residues reported in 2002 were successfully suppressed to less than 100 cases annually by 2006 and on, the number of notification cases for pesticide residues showed a gradual increase from a low (approximately 50 cases annually initial level until 2005 to more than 250 cases annually after 2009, with a halt occurring only in 2016. Main notifiers of VD residues include Germany, Belgium, the UK, and Italy (63, 59, 42, and 31 notifications announced, respectively, and main consigning countries of non-compliances are Vietnam, India, China, and Brazil (88, 50, 34, and 23 notifications, respectively. Thus, countries of South and Southeast Asia are considered a vulnerable point with regard to VD residues entering the EU market. Unintended side effects of VDs and plant protection products may be caused not only by the active ingredients but also by various additives in these preparations. Adjuvants (e.g., surfactants and other co-formulants used in therapeutic agents and feed additives, as well as in pesticide formulations have long been considered as inactive ingredients in the aspects of the required main biological effect of the pharmaceutical or pesticide, and in turn, legal regulations of the approval and marketing of these additives specified significantly less stringent risk assessment requirements, than those specified for the active ingredients. However, numerous studies have shown additive, synergistic, or antagonistic side effects

  4. Authorization and Toxicity of Veterinary Drugs and Plant Protection Products: Residues of the Active Ingredients in Food and Feed and Toxicity Problems Related to Adjuvants

    Science.gov (United States)

    Klátyik, Szandra; Bohus, Péter; Darvas, Béla; Székács, András

    2017-01-01

    Chemical substances applied in animal husbandry or veterinary medicine and in crop protection represent substantial environmental loads, and their residues occur in food and feed products. Product approval is governed differently in these two sectors in the European Union (EU), and the occurrence of veterinary drug (VD) and pesticide residues indicated by contamination notification cases in the Rapid Alert System for Food and Feed of the EU also show characteristic differences. While the initial high numbers of VD residues reported in 2002 were successfully suppressed to less than 100 cases annually by 2006 and on, the number of notification cases for pesticide residues showed a gradual increase from a low (approximately 50 cases annually) initial level until 2005 to more than 250 cases annually after 2009, with a halt occurring only in 2016. Main notifiers of VD residues include Germany, Belgium, the UK, and Italy (63, 59, 42, and 31 notifications announced, respectively), and main consigning countries of non-compliances are Vietnam, India, China, and Brazil (88, 50, 34, and 23 notifications, respectively). Thus, countries of South and Southeast Asia are considered a vulnerable point with regard to VD residues entering the EU market. Unintended side effects of VDs and plant protection products may be caused not only by the active ingredients but also by various additives in these preparations. Adjuvants (e.g., surfactants) and other co-formulants used in therapeutic agents and feed additives, as well as in pesticide formulations have long been considered as inactive ingredients in the aspects of the required main biological effect of the pharmaceutical or pesticide, and in turn, legal regulations of the approval and marketing of these additives specified significantly less stringent risk assessment requirements, than those specified for the active ingredients. However, numerous studies have shown additive, synergistic, or antagonistic side effects between the

  5. Regulatory Perspectives on Strength-Dependent Dissolution Profiles and Biowaiver Approaches for Immediate Release (IR) Oral Tablets in New Drug Applications.

    Science.gov (United States)

    Suarez-Sharp, Sandra; Delvadia, Poonam R; Dorantes, Angelica; Duan, John; Externbrink, Anna; Gao, Zongming; Ghosh, Tapash; Miksinski, Sarah Pope; Seo, Paul

    2016-05-01

    Dissolution profile comparisons are used by the pharmaceutical industry to assess the similarity in the dissolution characteristics of two formulations to decide whether the implemented changes, usually minor/moderate in nature, will have an impact on the in vitro/in vivo performance of the drug product. When similarity testing is applied to support the approval of lower strengths of the same formulation, the traditional approach for dissolution profile comparison is not always applicable for drug products exhibiting strength-dependent dissolution and may lead to incorrect conclusions about product performance. The objective of this article is to describe reasonable biopharmaceutic approaches for developing a biowaiver strategy for low solubility, proportionally similar/non-proportionally similar in composition immediate release drug products that exhibit strength-dependent dissolution profiles. The paths highlighted in the article include (1) approaches to address biowaiver requests, such as the use of multi-unit dissolution testing to account for sink condition differences between the higher and lower strengths; (2) the use of a single- vs. strength-dependent dissolution method; and (3) the use of single- vs. strength-dependent dissolution acceptance criteria. These approaches are cost- and time-effective and can avoid unnecessary bioequivalence studies.

  6. Bioavailability and Bioequivalence in Drug Development.

    Science.gov (United States)

    Chow, Shein-Chung

    2014-01-01

    Bioavailability is referred to as the extent and rate to which the active drug ingredient or active moiety from the drug product is absorbed and becomes available at the site of drug action. The relative bioavailability in terms of the rate and extent of drug absorption is considered predictive of clinical outcomes. In 1984, the United States Food and Drug Administration (FDA) was authorized to approve generic drug products under the Drug Price Competition and Patent Term Restoration Act based on evidence of average bioequivalence in drug absorption through the conduct of bioavailability and bioequivalence studies. This article provides an overview (from an American point of view) of definition of bioavailability and bioequivalence, Fundamental Bioequivalence Assumption, regulatory requirements, and process for bioequivalence assessment of generic drug products. Basic considerations including criteria, study design, power analysis for sample size determination, and the conduct of bioequivalence trial, and statistical methods are provided. Practical issues such as one size-fits-all criterion, drug interchangeability and scaled average criteria for assessment of highly variable drug products are also discussed.

  7. 77 FR 52711 - Sabine River Authority of Texas and Sabine River Authority, State of Louisiana; Notice of...

    Science.gov (United States)

    2012-08-30

    ... Energy Regulatory Commission Sabine River Authority of Texas and Sabine River Authority, State of... filed: September 30, 2011 (application); August 1, 2012 (offer of settlement). d. Applicant: Sabine River Authority of Texas and Sabine River Authority, State of Louisiana (Sabine River Authorities)....

  8. Data Integrity-A Study of Current Regulatory Thinking and Action.

    Science.gov (United States)

    Shafiei, Nader; De Montardy, Regis; Rivera-Martinez, Edwin

    2015-01-01

    In reaction to breaches of data integrity in the pharmaceutical industry, regulatory authorities have introduced inspection approaches or initiatives with the aim of reducing occurrences of data integrity problems. This review article-based on study of 65 cases of regulatory action from 2002 to 2014-provides an overview of current regulatory thinking and action on breaches of data integrity affecting GxP (health-related regulations) processes supporting non-clinical studies, clinical studies, laboratory controls, and production controls. These case studies largely represent position of the U.S. Food and Drug Administration and the regulatory agencies affiliated with the European Medicines Agency. Also discussed is the role of human factors as a potential source of data integrity problems. The article concludes by recommending some remedial controls that could be established to avoid or reduce occurrences of data integrity problems.Lay Abstract: In fulfilling their mission to protect public health, regulatory agencies (e.g., U.S. Food and Drug Administration, European Medicines Agency) must establish confidence that medical products they approve are fit for their intended use. In so doing they rely on scientific and operational data generated during research, development, manufacturing, sales, marketing, distribution, and post-marketing surveillance activities. The level of confidence they build is directly proportional to the scientific validity and integrity of data presented to them by the sponsors of medical products. In this article we present analysis of 65 case studies that document regulatory action taken by various regulatory agencies on breach of data integrity between 2002 and 2014. The ensuing discussion on current trends largely represents position of the U.S. Food and Drug Administration and European Medicines Agency. The article concludes by proposing some remedial controls that could be established by pharmaceutical companies to avoid or reduce

  9. Licenced to pollute but not to poison: The ineffectiveness of regulatory authorities at protecting public health from atmospheric arsenic, lead and other contaminants resulting from mining and smelting operations

    Science.gov (United States)

    Taylor, Mark Patrick; Davies, Peter J.; Kristensen, Louise Jane; Csavina, Janae Lynn

    2014-09-01

    regulatory framework fails to protect the impacted communities.

  10. Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development

    Science.gov (United States)

    Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar

    2016-01-01

    Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity. It is advantageous being a green synthesis approach for production of pharmaceutical compounds. The formation polymorphic forms, solvates, hydrates and salts of cocrystals during the synthesis reported in the literature which can be a potential issue in the development of pharmaceutical cocrystals. The approaches like hydrogen bonding rules, solubility parameters, screening through the CSD database or thermodynamic characteristics can be utilized for the rational design of cocrystals and selection of coformers for synthesis multi-component cocrystals. Considering the significance of pharmaceutical cocrystals pharmaceutical regulatory authorities in the United States and Europe issued guidance documents which may be helpful for pharmaceutical product registration in these regions. In this article, we deal with the design, synthesis, strategic aspects and characteristics of cocrystals along perspectives on its regulatory and intellectual property considerations.

  11. Clinical trials information in drug development and regulation : existing systems and standards

    NARCIS (Netherlands)

    Valkenhoef, Gert van; Tervonen, Tommi; Brock, Bert de; Hillege, Hans

    2012-01-01

    Clinical trials provide pivotal evidence on drug efficacy and safety. The evidence, information from clinical trials, is currently used by regulatory decision makers in marketing authorization decisions, but only in an implicit manner. For clinical trials information to be used in a transparent and

  12. 18 CFR 3a.2 - Authority.

    Science.gov (United States)

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Authority. 3a.2 Section 3a.2 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL RULES NATIONAL SECURITY INFORMATION General § 3a.2 Authority. Official information...

  13. 76 FR 50741 - 2011 Parenteral Drug Association/Food and Drug Administration Joint Public Conference; Quality...

    Science.gov (United States)

    2011-08-16

    ... HUMAN SERVICES Food and Drug Administration 2011 Parenteral Drug Association/Food and Drug Administration Joint Public Conference; Quality and Compliance in Today's Regulatory Enforcement Environment AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and...

  14. Recommendations for an update of 2003 European regulatory requirements for registration of drugs to be used in the treatment of RA.

    Science.gov (United States)

    Smolen, Josef S; Boers, Maarten; Abadie, Eric C; Breedveld, Ferdinand C; Emery, Paul; Bardin, Thomas; Goel, Niti; Ethgen, Dominique J; Avouac, Bernard P; Dere, Willard H; Durez, Patrick; Matucci-Cerinic, Marco; Flamion, Bruno; Laslop, Andrea; Lekkerkerker, Frits J; Miossec, Pierre; Mitlak, Bruce H; Ormarsdóttir, Sif; Paolozzi, Laurence; Rao, Ravi; Reiter, Susan; Tsouderos, Yannis; Reginster, Jean-Yves

    2011-02-01

    Since 2003, the European Medicines Agency (EMA) document, 'Points to consider on clinical investigation of medicinal products other than NSAIDs (nonsteroidal anti-inflammatory drugs) for the treatment of rheumatoid arthritis' has provided guidance for the clinical development of both biologic and non-biologic disease-modifying antirheumatic drugs (DMARDs). In the last few years, several new products have been developed or are in development for the treatment of RA, which offer significant efficacy with regard to disease control, including prevention of structural damage and disability. Concurrently, novel insights have been gained with respect to the assessment of disease activity, joint damage and disability. New treatment strategies have been established which relate to early therapy, tight control and rapid switching of medication. Accordingly, several new EULAR/ACR recommendations have been or are being developed. Several important additions and changes are needed in the 2003 guidance to incorporate the current scientific knowledge into clinical trial design for the development of future products. Under the auspices of the Group for the Respect of Ethics and Excellence in Science (GREES), a group of experts in the field of RA and clinical trial design met to provide a consensus recommendation for an update to the 2003 EMA guidance document.

  15. 对民营企业境外间接发行上市监管的域外效力——“裕兴”案引发的思考%Extraterritorial Effect of Regulatory Authority on Indirect Issuing and Listing Security Abroad by Chinese Privately Owned Enterprises — — the “ Yu Xing” Case and Beyond

    Institute of Scientific and Technical Information of China (English)

    王千华

    2001-01-01

    Chinese security authority possesses extraterritorial jurisdiction over indirect issuing and listing security abroad by Chinese privately owned enterprises. In order to reduce the international jurisdiction disputes and strengthen the principle of rule of law, jurisdictional privileges of foreign security authorities should be fully respected. The principles of limited extraterritorial regulatory authority and administration under transparency shall be established to facilitate financing abroad by Chinese privately owned enterprises.%境内证券监管部门有权就民营企业在境外间接发行股票并上市交易的行为进行域外监管。从减少管辖冲突和完善依法治国的原则出发,应尊重境外监管机构的管辖权力,确立有条件的域外监管原则和监管透明原则,以支持民营企业出境筹资。

  16. Nuclear safety assessment of nuclear power plants and nuclear risk in Eastern Europe and other regions. Scientific-technical cooperation with nuclear regulatory authorities and technical support organizations (TSOs); Einschaetzung der nuklearen Sicherheit von Kernkraftwerken sowie nuklearer Risiken in Osteuropa und anderen Regionen. Wissenschaftlich-technische Zusammenarbeit mit atomrechtlichen Behoerden und deren Sachverstaendigenorganisationen (TSO)

    Energy Technology Data Exchange (ETDEWEB)

    Wolff, Holger

    2014-09-15

    The BMUB/BfS project 3611I01512 formed the frame of the GRS for the scientifictechnical cooperation with Technical Support Organisations and Nuclear Regulatory Authorities in the field of nuclear safety of NPPs and for the evaluation of nuclear risks in Eastern Europe and other regions for the period from September 2011 till June 2014. In the present final report main results of the project are described. The project comprised the following technical topics: - Record status of NPP modernisation programs, Monitoring and evaluation of modernisation programs; - Design basis and severe accident analyses for NPP with PWR (WWER-440, WWER-1000); - Cooperation with INSC partner countries on DBA, BDBA and severe accident analyses for WWER plants of generation 3+ and on building NRA and safety evaluation capacities; - Decommissioning of nuclear facilities and disposal of radioactive waste; - Evaluation of new reactor concepts and their safety design; Panels at regulatory level. The work results are preceded by a summary on the activities related to the project management and to the planning of the bilateral work.

  17. What's the Regulatory Value of a Target Product Profile?

    Science.gov (United States)

    Breder, Christopher D; Du, Wenny; Tyndall, Adria

    2017-07-01

    Target product profiles (TPPs) are used as a regulatory tool for dialog on clinical development or manufacturing plans. Drugs and biologics approved by the FDA that mention TPPs are associated with more efficient regulatory review times, perhaps as a result of increased planning or because the TPP promotes well-organized regulatory dialog. Published by Elsevier Ltd.

  18. 76 FR 76168 - Regulatory Site Visit Training Program

    Science.gov (United States)

    2011-12-06

    ... HUMAN SERVICES Food and Drug Administration Regulatory Site Visit Training Program AGENCY: Food and Drug... and quality, and the quality of its regulatory efforts and interactions, by providing CBER staff with... coordination of CBER's priorities for staff training as well as the limited available resources for this...

  19. 76 FR 4919 - Regulatory Site Visit Training Program

    Science.gov (United States)

    2011-01-27

    ... HUMAN SERVICES Food and Drug Administration Regulatory Site Visit Training Program AGENCY: Food and Drug... quality, and the quality of its regulatory efforts and interactions, by providing CBER staff with a better... priorities for staff training as well as the limited available resources for this program. In addition to...

  20. 40 CFR 73.86 - State regulatory autonomy.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false State regulatory autonomy. 73.86 Section 73.86 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... regulatory autonomy. Nothing in this subpart shall preclude a State or State regulatory authority...

  1. Developing a paradigm of drug innovation: an evaluation algorithm.

    Science.gov (United States)

    Caprino, Luciano; Russo, Pierluigi

    2006-11-01

    Assessment of drug innovation is a burning issue because it involves so many different perspectives, mainly those of patients, decision- and policy-makers, regulatory authorities and pharmaceutical companies. Moreover, the innovative value of a new medicine is usually an intrinsic property of the compound, but it also depends on the specific context in which the medicine is introduced and the availability of other medicines for treating the same clinical condition. Thus, a model designed to assess drug innovation should be able to capture the intrinsic properties of a compound (which usually emerge during R&D) and/or modification of its innovative value with time. Here we describe the innovation assessment algorithm (IAA), a simulation model for assessing drug innovation. IAA provides a score of drug innovation by assessing information generated during both the pre-marketing and the post-marketing authorization phase.

  2. Participation of the Nuclear Regulatory Authority in the 'Third European Intercomparison Exercise on Internal Dose Assessment'; Participacion de la Autoridad Regulatoria Nacional en el 'Tercer Ejercicio Europeo de Intercomparacion en Dosimetria de la Contaminacion Interna'

    Energy Technology Data Exchange (ETDEWEB)

    Rojo, Ana Maria; Gomez Parada, Ines Maria [Autoridad Regulatoria Nuclear, Buenos Aires (Argentina)

    2001-07-01

    This paper resume the participation of the Argentine Nuclear Regulatory Authority (ARN) in the 'Third European Intercomparison Exercise on Internal Dose Assessment'. It takes place during 5 months in 1998 and the final meeting was held in Weimar, Germany, on May 1999. This exercise involved the previous distribution of seven cases, simulated and real, describing possible incorporations of radioactive materials. There was a description of the event, data of retention or excretion measurements and air concentration data. The fifty participants belong to twenty three countries had do solve the cases and informed the results to the organizers, mainly the incorporation and effective dose was required. The objective was to review the methodology, the codes and the different assumptions used by the participants for discussing the consistent of the result. The results are shown through tables including the maximum and minimum values gave for the final report and the results informed by ARN. This exercise allowed to compare the methodology used by the ARN internal dosimetry group with other choose by several international groups to assure that the codes, assumptions and methodology were satisfactory to solve the different cases given by the organizers. (author)

  3. Drug Preferences of Multiple Drug Abusers.

    Science.gov (United States)

    Harford, Robert J.

    1978-01-01

    Examined drug preferences of a group of active multiple drug abusers referred for treatment. Nearly half the respondents preferred drugs other than type they most frequently used. Preferences were related to method of administration. Results suggest preference is one among several determinants of drug use. (Author/BEF)

  4. 78 FR 46656 - Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Notice of Filing of...

    Science.gov (United States)

    2013-08-01

    ... Proposed Plan for the Allocation of Regulatory Responsibilities Between the Financial Industry Regulatory..., Topaz Exchange, LLC (``Topaz'') and the Financial Industry Regulatory Authority, Inc. (``FINRA... text of the proposed 17d-2 Plan is as follows: Agreement Between Financial Industry...

  5. Rational Use of Drugs: Pharmaceutical Aspects of the Drug Selection

    Directory of Open Access Journals (Sweden)

    Natalya B. Rostova, PhD, ScD

    2012-09-01

    Full Text Available In this article, the problems encountered in the rational use of drugs are discussed, one of the areas of optimization of drug supply being the rational choice of drugs, particularly, a regulatory activity regarding the approach to the selection of standardized drug lists (drug formulary for public drug supply, according to government guarantees and programs. The clinical aspects of the drug selection are expounded in detail. The characteristics of the drugs (original or generic drug (generics, the origin of drugs and the breadth of therapeutic index, have been taken into account. Certain stages have been analyzed, particularly drug use in individual diseases, drug selection, expert drug evaluation, and expert recommendations to include specific drugs in the drug list. Organizational steps have been proposed to implement the rational choice of drugs to be included in the drug formulary.

  6. Existing FDA pathways have potential to ensure early access to, and appropriate use of, specialty drugs.

    Science.gov (United States)

    Kesselheim, Aaron S; Tan, Yongtian Tina; Darrow, Jonathan J; Avorn, Jerry

    2014-10-01

    Specialty drugs are notable among prescription drugs in that they offer the possibility of substantial clinical improvement, come with important risks of adverse events and mortality, can be complex to manufacture or administer, and are usually extremely costly. The Food and Drug Administration (FDA) plays a critical role in ensuring that patients who could benefit from specialty drugs have access to them in a timely fashion. In this article we review the different strategies that the FDA can use to approve and influence the post-approval prescribing of specialty drugs. When specialty drugs show promise in early clinical trials, the FDA can expedite the drugs' availability to patients through expanded access programs and expedited approval pathways that speed regulatory authorization. After approval, to ensure that specialty drugs are directed to the patients who are most likely to benefit from them, the FDA can limit the scope of the drugs' indications, encourage the development of companion diagnostic tests to indicate which patients should receive the drugs, or require that manufacturers subject them to Risk Evaluation and Mitigation Strategies to ensure that their use is appropriately limited to a restricted population that is aware of the drugs' risks and benefits. Implementing these existing regulatory approaches can promote timely patient access to specialty drugs while preventing expensive and potentially inappropriate overuse.

  7. Orphan drugs

    Directory of Open Access Journals (Sweden)

    Goločorbin-Kon Svetlana

    2013-01-01

    Full Text Available Introduction. Drugs used for treatment of rare diseases are known worldwide under the term of orphan drugs because pharmaceutical companies have not been interested in ”adopting” them, that is in investing in research, developing and producing these drugs. This kind of policy has been justified by the fact that these drugs are targeted for small markets, that only a small number of patients is available for clinical trials, and that large investments are required for the development of drugs meant to treat diseases whose pathogenesis has not yet been clarified in majority of cases. The aim of this paper is to present previous and present status of orphan drugs in Serbia and other countries. The beginning of orphan drugs development. This problem was first recognized by Congress of the United States of America in January 1983, and when the ”Orphan Drug Act” was passed, it was a turning point in the development of orphan drugs. This law provides pharmaceutical companies with a series of reliefs, both financial ones that allow them to regain funds invested into the research and development and regulatory ones. Seven years of marketing exclusivity, as a type of patent monopoly, is the most important relief that enables companies to make large profits. Conclusion. There are no sufficient funds and institutions to give financial support to the patients. It is therefore necessary to make health professionals much more aware of rare diseases in order to avoid time loss in making the right diagnosis and thus to gain more time to treat rare diseases. The importance of discovery, development and production of orphan drugs lies in the number of patients whose life quality can be improved significantly by administration of these drugs as well as in the number of potential survivals resulting from the treatment with these drugs. [Projekat Ministarstva nauke Republike Srbije, br. III 41012

  8. Fluorescence anisotropy (polarization): from drug screening to precision medicine

    Science.gov (United States)

    Zhang, Hairong; Wu, Qian; Berezin, Mikhail Y.

    2016-01-01

    Introduction Fluorescence anisotropy (FA) is one of the major established methods accepted by industry and regulatory agencies for understanding the mechanisms of drug action and selecting drug candidates utilizing a high-throughput format. Areas covered This review covers the basics of FA and complementary methods, such as fluorescence lifetime anisotropy and their roles in the drug discovery process. The authors highlight the factors affecting FA readouts, fluorophore selection, and instrumentation. Furthermore, the authors describe the recent development of a successful, commercially valuable FA assay for Long QT syndrome drug toxicity to illustrate the role that FA can play in the early stages of drug discovery. Expert opinion Despite the success in drug discovery, the FA-based technique experiences competitive pressure from other homogeneous assays. That being said, FA is an established yet rapidly developing technique, recognized by academic institutions, the pharmaceutical industry, and regulatory agencies across the globe. The technical problems encountered in working with small molecules in homogeneous assays are largely solved, and new challenges come from more complex biological molecules and nanoparticles. With that, FA will remain one of the major work-horse techniques leading to precision (personalized) medicine. PMID:26289575

  9. International Guidelines for Bioequivalence of Systemically Available Orally Administered Generic Drug Products: A Survey of Similarities and Differences

    OpenAIRE

    Davit, Barbara; Braddy, April C.; Conner, Dale P.; Yu, Lawrence X.

    2013-01-01

    The objective of this article is to discuss the similarities and differences among bioequivalence approaches used by international regulatory authorities when reviewing applications for marketing new generic drug products which are systemically active and intended for oral administration. We focused on the 13 jurisdictions and organizations participating in the International Generic Drug Regulators Pilot. These are Australia, Brazil, Canada, China, Chinese Taipei, the European Medicines Assoc...

  10. Affordable orphan drugs: a role for not-for-profit organizations.

    Science.gov (United States)

    Davies, Elin H; Fulton, Emma; Brook, Daniel; Hughes, Dyfrig A

    2017-07-01

    The success of the Regulation on Orphan Medicinal Products in the European Union is evidenced by the 127 orphan drugs that have had market authorization since 2000. However, the incentives aimed at stimulating research and development have had the unintended consequence of increasing drug cost, resulting in many orphan drugs not being cost-effective. Orphan drugs command an increasing share of the pharmaceutical market and account for a disproportionate amount of healthcare expenditure. Orphan drug ownership by socially motivated, not-for-profit organizations may facilitate access to more affordable orphan drugs, for the benefit of patients and healthcare systems alike. This study aims to describe opportunities for such organizations to become orphan drug Market Authorization Holders. We reviewed data on the ownership of EMA designated and approved orphan drugs, identified funding opportunities and business models for not-for-profit organizations, and summarised relevant legal and policy documents concerning intellectual property rights and drug regulation. Using repurposed drugs as a paradigm, this narrative review navigates the regulatory hurdles, describes the legal context and identifies funding opportunities, in a bid to facilitate and encourage not-for-profit organizations to lead on the development of affordable orphan drugs. Although the regulatory steps required to obtain an MA for an orphan drug are numerous and challenging, they are not insurmountable and can be achieved by not-for-profit organizations that are socially motivated to reduce the costs of orphan drugs to the payers of healthcare. Opportunities for orphan drug development resulting in affordable products lie mainly with repurposed drugs. © 2017 The British Pharmacological Society.

  11. 76 FR 38243 - Self-Regulatory Organizations; BATS Exchange, Inc.; BATS Y-Exchange, Inc.; NASDAQ OMX BX, Inc...

    Science.gov (United States)

    2011-06-29

    ... Exchange, Inc.; Financial Industry Regulatory Authority, Inc.; International Securities Exchange LLC; The... Industry Regulatory Authority, Inc. (``FINRA''), International Securities Exchange LLC (``ISE''), The... to fashion policy responses that will help prevent a recurrence.\\10\\ \\8\\ The events of May 6...

  12. [Mexico recovers leadership on regulation of biosimilar biotech drugs].

    Science.gov (United States)

    López Silva, Christian

    2012-01-01

    Amid the epidemiological transition that Mexico is currently experiencing, an adequate access to biotech medicines is becoming very important. However, these medicines also involve new challenges for the sanitary authorities, given their higher complexity in structure and function than conventional chemical drugs. Consequently, it has been necessary to update the Mexican legal framework, which has placed Mexico at the forefront in this sector. This article describes briefly what biotech drugs are, why it has been necessary to regulate them differently, the evolution of the regulatory framework in Mexico, and the general features of the new system.

  13. ATMPs for Cancer Immunotherapy: A Regulatory Overview.

    Science.gov (United States)

    Galli, Maria Cristina

    2016-01-01

    This chapter discusses European regulatory requirements for development of advanced therapy medicinal products (ATMP) for cancer immunotherapy approaches, describing the framework for clinical trials and for marketing authorization.Regulatory critical issues and challenges for developing ATMP are also discussed, with focus on potency determination, long-term follow-up, comparability, and insertional mutagenesis issues. Some of the most critical features of GMP application to ATMP are also described.

  14. 10 CFR 60.31 - Construction authorization.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Construction authorization. 60.31 Section 60.31 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC..., technical and other benefits against environmental costs and considering available alternatives, the...

  15. 10 CFR 63.31 - Construction authorization.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Construction authorization. 63.31 Section 63.31 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN A GEOLOGIC...) Environmental. That, after weighing the environmental, economic, technical, and other benefits...

  16. Comparison of the Explantation Rate of Poly Implant Prothèse, Allergan, and Pérouse Silicone Breast Implants within the First Four Years after Reconstructive Surgery before the Poly Implant Prothèse Alert by the French Regulatory Authority

    Directory of Open Access Journals (Sweden)

    Alexandre Leduey

    2015-01-01

    Full Text Available Background. In March 2010, ANSM (Agence Nationale de Sécurité du Medicament, the French Medical Regulatory Authority, withdrew Poly Implant Prothèse (PIP breast implants from the market due to the use of non-medical-grade silicone gel. The aim of this study was to compare the removal rate (and reasons thereof of breast implants produced by different manufacturers before the ANSM alert. Materials and Methods. From October 2006 to January 2010, 652 women received 944 implants after breast cancer surgery at the Gustave Roussy Comprehensive Cancer Center, Paris (France. The complications and removal rates of the different implant brands used (PIP, Allergan, and Pérouse were evaluated and compared. Results. PIP implants represented 50.6% of the used implants, Allergan 33.4%, and Pérouse 16%. The main reasons for implant removal were patient dissatisfaction due to aesthetic problems (43.2%, infection (22.2%, and capsular contracture (13.6%. Two years after implantation, 82% of Pérouse implants, 79% of PIP, and 79% of Allergan were still in situ. There was no difference in removal rate among implant brands. Conclusion. Before the ANSM alert concerning the higher rupture rate of PIP breast implants, our implant removal rate did not predict PIP implant failure related to the use of nonapproved silicone gel.

  17. Good clinical practice regulatory inspections: Lessons for Indian investigator sites

    Directory of Open Access Journals (Sweden)

    R Marwah

    2010-01-01

    Full Text Available Regulatory inspections are important to evaluate the integrity of the data submitted to health authorities (HAs, protect patient safety, and assess adequacy of site/sponsor quality systems to achieve the same. Inspections generally occur after submission of data for marketing approval of an investigational drug. In recent years, there has been a significant increase in number of inspections by different HAs, including in India. The assessors/inspectors generally do a thorough review of site data before inspections. All aspects of ICH-GCP, site infrastructure, and quality control systems are assessed during the inspection. Findings are discussed during the close out meeting and a detailed inspection report issued afterward, which has to be responded to within 15-30 days with effective Corrective and Preventive Action Plan (CAPA. Protocol noncompliance, inadequate/inaccurate records, inadequate drug accountability, informed consent issues, and adverse event reporting were some of the most common findings observed during recent Food and Drug Administration (FDA inspections. Drug development is being increasingly globalized and an increased number of patients enrolled in studies submitted as part of applications come from all over the world including India. Because of the steep increase in research activity in the country, inexperienced sites, and more stakeholders, increased efforts will be required to ensure continuous quality and compliance. HAs have also made clear that enforcement will be increased and be swift, aggressive, and effective.

  18. An evaluation of the contribution of the Swedish International Development Authority (SIDA) to leprosy control in India based on the implementation of multiple drug therapy (MDT) 1981-1993.

    Science.gov (United States)

    Peat, M; Brolin, L; Ganapati, R; McDougall, A C; Revankar, C R; Watson, J W

    1995-01-01

    The Swedish International Development Authority (SIDA) first supported the National Leprosy Control Programme in India in 1978. In 1981/82 priority was given to the implementation of multiple drug therapy (MDT), starting in two high-endemic districts, and gradually extending to a total of 19 districts in the years by 1993. SIDA then decided to undertake a detailed evaluation of its 12-year contribution and this was carried out by an international team between November 1993 and April 1994. In terms of epidemiological and public health impact, the main results were impressive and clear-cut; 837,519 cases (old and newly arising) were successfully treated, with few complications and a low rate of relapse. The voluntary reporting rate had improved significantly. Data relating to new case detection, child and disability rates were, however, less clear and difficult to interpret. Deficiencies were also identified in the areas of health education, community participation, gender issues, disability prevention and management, rehabilitation, operational research and assessment of cost-effectiveness. These problems should not, however, detract from the contribution of SIDA, from 1981 onwards, in establishing the implementation of MDT in two 'pilot' districts at an early and important stage in the history of the MDT programme in India. SIDA also made significant contributions in other areas, namely pre-MDT 'screening' of registers in 45 endemic districts in 1990-1993, appointment of consultant leprologists at district level, group education activities, annual meetings of voluntary agencies and the development of a monitoring and information system, with computer facilities, at national level. This paper describes the design and methodology, main findings and conclusions of the evaluation, based on the final report and the appendices submitted to SIDA in Stockholm in April 1994.

  19. 中国制药企业在美国市场中应对授权仿制药竞争的策略研究%Research on Strategy of China Pharmaceutical Companies Coping with Competition of Authorized Generics in American Drug Market

    Institute of Scientific and Technical Information of China (English)

    刘立春; 朱雪忠

    2013-01-01

    OBJECTIVE To study the principle,feature and impact of the authorized generics strategy in American drug market,thus to provide some references for Chinese scholars who research the authorized generics strategy and for China pharmaceutical companies that would face competition in American pharmaceutical market.METHODS By case study and policies analysis,the ways how the brand-name companies used the authorized generics in American drug market were summarized.RESULTS AND CONCLUSION Successful authorized generics strategy can maintain a large market share of the brand-name companies'products.In American drug market,there are some particularities about the authorize generics strategy due to the features of American drug policies and regulations.China pharmaceutical companies should implement different authorized generics strategy according to their own conditions in American drug market at present.%目的 通过对美国授权仿制药战略原理、特点以及影响进行研究,为中国学者探讨授权仿制药战略以及中国制药企业在美国市场面临授权仿制药竞争时提供借鉴.方法 通过案例分析和政策解析,总结品牌药厂商在美国市场中使用授权仿制药策略的特点.结论与结果 成功的授权仿制药战略能够使品牌药厂商的产品在专利到期后仍能后维持较大的市场份额.中国制药企业需要根据自身的情况在美国市场选择不同的授权仿制药策略.

  20. Summary report of PQRI Workshop on Nanomaterial in Drug Products: current experience and management of potential risks.

    Science.gov (United States)

    Bartlett, Jeremy A; Brewster, Marcus; Brown, Paul; Cabral-Lilly, Donna; Cruz, Celia N; David, Raymond; Eickhoff, W Mark; Haubenreisser, Sabine; Jacobs, Abigail; Malinoski, Frank; Morefield, Elaine; Nalubola, Ritu; Prud'homme, Robert K; Sadrieh, Nakissa; Sayes, Christie M; Shahbazian, Hripsime; Subbarao, Nanda; Tamarkin, Lawrence; Tyner, Katherine; Uppoor, Rajendra; Whittaker-Caulk, Margaret; Zamboni, William

    2015-01-01

    At the Product Quality Research Institute (PQRI) Workshop held last January 14-15, 2014, participants from academia, industry, and governmental agencies involved in the development and regulation of nanomedicines discussed the current state of characterization, formulation development, manufacturing, and nonclinical safety evaluation of nanomaterial-containing drug products for human use. The workshop discussions identified areas where additional understanding of material attributes, absorption, biodistribution, cellular and tissue uptake, and disposition of nanosized particles would continue to inform their safe use in drug products. Analytical techniques and methods used for in vitro characterization and stability testing of formulations containing nanomaterials were discussed, along with their advantages and limitations. Areas where additional regulatory guidance and material characterization standards would help in the development and approval of nanomedicines were explored. Representatives from the US Food and Drug Administration (USFDA), Health Canada, and European Medicines Agency (EMA) presented information about the diversity of nanomaterials in approved and newly developed drug products. USFDA, Health Canada, and EMA regulators discussed the applicability of current regulatory policies in presentations and open discussion. Information contained in several of the recent EMA reflection papers was discussed in detail, along with their scope and intent to enhance scientific understanding about disposition, efficacy, and safety of nanomaterials introduced in vivo and regulatory requirements for testing and market authorization. Opportunities for interaction with regulatory agencies during the lifecycle of nanomedicines were also addressed at the meeting. This is a summary of the workshop presentations and discussions, including considerations for future regulatory guidance on drug products containing nanomaterials.

  1. Challenges in the clinical development requirements for the marketing authorization of new medicines in southeast Asia.

    Science.gov (United States)

    Kudrin, Alex

    2009-03-01

    A rapid growth of investment into clinical research and new drug development has manifested itself by an exponential increase of new products coming onto the worldwide market. The emerging pharmaceutical and biotech markets in Southeast Asia are believed to be extremely promising from a commercial point of view in the next decade. The unique position of the Asian market and the diversity in clinical research initiatives are linked with diverse regulatory requirements for clinical development and registration of new medicines. Some of these differences have an impact on timelines for marketing authorizations in South Korea, China, Thailand, Japan, Singapore, and other countries. One of the approaches to streamlining regulatory strategy in different countries is the initiation of multicountry international clinical trials trying to address requirements and allowing registration in several regional countries simultaneously. Increasing cooperation between South Asian countries in relation to regulatory requirements and clinical development will facilitate the registration of innovative medicines in this rapidly developing region of the world and enable improved cohesiveness between countries in a drug safety framework.

  2. Quality Performance of Drugs Analyzed in the Drug Analysis and ...

    African Journals Online (AJOL)

    ICT TEAM

    During the period 2006-2010, the Drug Analysis and Research Unit analyzed 583 samples. ... drug products in the Kenyan market were imported ... Market authorization for pharmaceuticals in ..... sample size was very small, antibacterial drugs.

  3. The foreign experience of regulatory reform implementation and application of «regulatory guillotine»

    Directory of Open Access Journals (Sweden)

    N. M. Litvinova

    2014-09-01

    Full Text Available The foreign experience of regulatory reform implementation is considered. Particular attention is paid to the experience gained and the results of the use of “regulatory guillotine” as one of the kinds of regulatory reforms. The authors analyze the main preconditions and results of regulatory reforms and their impact on improved governance, creation of favorable conditions for business development, creating a positive investment climate. A certain degree of regulatory reform has become the standard for developed markets and for developing countries and are trying to take their place on stage one of the most developed countries. Study abroad experience in regulatory reforms in different countries of the world leads to the conclusion that the foundation for regulatory reform is a special system development and adoption of a special kind of legal acts - regulations. Unlike most legal acts, regulations, at the stage of the project should be accompanied by assessment or regulatory impact analysis, which provides comprehensive information about the possible positive or negative effects of the introduction of state regulation. Such adjustment shall be taken only when the overall benefits of regulation dominate the total cost of its implementation. The authors provide recommendations on the use of foreign experience in Ukraine

  4. Regulatory network operations in the Pathway Tools software

    Directory of Open Access Journals (Sweden)

    Paley Suzanne M

    2012-09-01

    Full Text Available Abstract Background Biologists are elucidating complex collections of genetic regulatory data for multiple organisms. Software is needed for such regulatory network data. Results The Pathway Tools software supports storage and manipulation of regulatory information through a variety of strategies. The Pathway Tools regulation ontology captures transcriptional and translational regulation, substrate-level regulation of enzyme activity, post-translational modifications, and regulatory pathways. Regulatory visualizations include a novel diagram that summarizes all regulatory influences on a gene; a transcription-unit diagram, and an interactive visualization of a full transcriptional regulatory network that can be painted with gene expression data to probe correlations between gene expression and regulatory mechanisms. We introduce a novel type of enrichment analysis that asks whether a gene-expression dataset is over-represented for known regulators. We present algorithms for ranking the degree of regulatory influence of genes, and for computing the net positive and negative regulatory influences on a gene. Conclusions Pathway Tools provides a comprehensive environment for manipulating molecular regulatory interactions that integrates regulatory data with an organism’s genome and metabolic network. Curated collections of regulatory data authored using Pathway Tools are available for Escherichia coli, Bacillus subtilis, and Shewanella oneidensis.

  5. 78 FR 49726 - International Framework for Nuclear Energy Cooperation Finance/Regulatory/Energy Planning...

    Science.gov (United States)

    2013-08-15

    ... International Trade Administration International Framework for Nuclear Energy Cooperation Finance/ Regulatory... International Framework for Nuclear Energy Cooperation (IFNEC)--to organize participation by representatives of... power projects, including national energy planning authorities, nuclear regulatory institutions, energy...

  6. 77 FR 14052 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-03-08

    ... sources). Standard 8 (Financial Controls): This standard seeks information regarding a continuing... information and documentation more consistent with the standards in NASD Rule 1014 (Department Decision... Principles of Trade): This standard consists of specific requests for information (e.g., disciplinary history...

  7. 75 FR 39715 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-07-12

    ... sphere, shall be considered conduct inconsistent with just and equitable principles of trade. Proposed... principles of trade, and, in general, to protect investors and the public interest. FINRA believes that the... may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available...

  8. 75 FR 55842 - Self-Regulatory Organizations; Financial Industry Regulatory Authority; Order Granting Approval...

    Science.gov (United States)

    2010-09-14

    ..., acting within its appropriate sphere, shall be considered conduct inconsistent with just and equitable... trade and, in general, to protect investors and the public interest.\\8\\ The rule change amends FINRA's... of trade and, in general, better protect investors and the public interest. \\8\\ 15 U.S.C. 78o-3(b)(6...

  9. 78 FR 9754 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-02-11

    ... capital'' means net capital reduced by the greater of the minimum dollar net capital requirement or two percent of combined aggregate debit items as shown in the Formula for Reserve Requirements pursuant to 17... change, as modified by Amendment No. 1, is consistent with the requirements of the Exchange Act, and the...

  10. 75 FR 56641 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2010-09-16

    ... for investors to trade at rational prices. In addition to the individual stock trading pause rules..., GETCO Letter, at 2, and SIFMA Letter, at 1-2 (also stating its belief that it is ``critical for the... be clearly erroneous,'' but stated its belief that ``its proposal reflects a significant improvement...

  11. 77 FR 77162 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-12-31

    ... ownership or corporate structuring as a result of a merger or acquisition, borrows a significant amount of... information to FINRA. However, with the growth of foreign securities markets and the ease at which trading can...

  12. 75 FR 21686 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-04-26

    ... (2010). Bankruptcy fraud is punishable by a fine, or by up to five years in prison, or both. Id. \\9\\ The... comments were neither solicited nor received. III. Date of Effectiveness of the Proposed Rule Change...

  13. 78 FR 79716 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc; Order Instituting...

    Science.gov (United States)

    2013-12-31

    ..., operations, and technology architecture for equities and debt that is tailored to the order lifecycle needs...\\ In this commenter's view, the costs of altering such architecture are not warranted.\\31\\ The first... Banking, Housing & Urban Affairs, S. Rep. No. 75, 94th Cong., 1st Sess. 30 (1975). Interested persons...

  14. 76 FR 59759 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-09-27

    ... associated with FINRA members have attained specified levels of competence and knowledge, consistent with... rulebook consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process... Kingdom Securities Representative. The revised content outline also includes a knowledge section...

  15. 75 FR 53362 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-08-31

    .... For more information about the rulebook consolidation process, see FINRA Information Notice, March 12, 2008 (Rulebook Consolidation Process). \\5\\ For convenience, the proposed rule change refers to... in outside business activities without the firm's prior knowledge. Potential investor harm could...

  16. 76 FR 59751 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-09-27

    ... associated with FINRA members have attained specified levels of competence and knowledge, consistent with... a more limited application by their terms. For more information about the rulebook consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process). For convenience, the...

  17. 78 FR 64566 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2013-10-29

    ... knowledge, consistent with applicable registration requirements under FINRA rules. FINRA periodically... application by their terms. For more information about the rulebook consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process). \\10\\ See also Incorporated NYSE Rule 345.15(3...

  18. 76 FR 59761 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-09-27

    ... associated with FINRA members have attained specified levels of competence and knowledge, consistent with... rulebook consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process... questions that assess knowledge of options since individuals wishing to sit for the Series 37 examination...

  19. 76 FR 59757 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-09-27

    ... associated with FINRA members have attained specified levels of competence and knowledge, consistent with... rulebook consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process... Series 37 examination, the Series 38 examination does not include test questions that assess knowledge of...

  20. 78 FR 71695 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-11-29

    ... Stop Stock price or within 10 seconds of the prior reference time, then the designated modifier should...:15 a.m. the next business day following execution with the unique trade report modifier to denote... 7140, 7240A, 7240B and 7340 will not impact the way members report to FINRA and will not...

  1. 77 FR 33539 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-06-06

    ... (Application for Approval of Change in Ownership, Control, or Business Operations) and to adopt Form CMA... a change in ownership, control, or business operations consistent with Rule 1017. The proposed rule... requires members, upon specified changes in ownership, control, or business operations, to file...

  2. 78 FR 66405 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Instituting...

    Science.gov (United States)

    2013-11-05

    ... undertakes efforts to build out the system to support the member, and in either instance, the member fails to... organization. See Securities Act Amendments of 1975, Senate Comm. on Banking, Housing & Urban Affairs, S. Rep...

  3. 77 FR 35457 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-06-13

    ..., 2011 (``NSCP Letter''); William A. Jacobson, Associate Clinical Professor, and Carolyn L. Nguyen.... Jacobson, Associate Clinical Professor of Law, Cornell Law School, and Director, Cornell Securities Law... enactment of the Jumpstart Our Business Startups Act of 2012 (``JOBS Act''). In particular, the...

  4. 75 FR 72850 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-11-26

    ... without an aggregate limit of liability. Members may apply for this level of coverage with any product... premises, in transit, forgery and alteration, securities and counterfeit currency. The proposed rule change... that the proposal creates an uneven playing field in that it promotes certain underwriters and products...

  5. 77 FR 1773 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-01-11

    ... under the Fair Labor Standards Act (FLSA), the Age Discrimination in Employment Act (ADEA), or the Equal.... Department of Labor, ``What does the Fair Labor Standards Act require?,'' elaws--Fair Labor Standards Act... Securities Exchange Act of 1934 (``Act'') \\1\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on...

  6. 75 FR 39603 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-07-09

    ... 240.10b-17. Rule 10b-17 requires issuers to give FINRA, in a timely fashion, information relating to... timely fashion in order to provide adequate notice to market participants. Further, FINRA states that the... whether issuers that are not designated as eligible for the DTC's FAST systems would have their...

  7. 77 FR 14850 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-03-13

    ... counterparty credit risk posed by CDS, including, among other things, risks to the financial system arising from credit risk resulting from bilateral CDS transactions and from a concentration of credit risk to a... Requirements for Credit Default Swaps) March 7, 2012. Pursuant to Section 19(b)(1) of the Securities Exchange...

  8. 78 FR 60982 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2013-10-02

    ... designate a member of senior management to approve a business continuity plan and to be responsible for the...) and FINRA Rule 4370(f) (Business Continuity and Emergency Contact Information), which requires a... business continuity plan and disclosure of such to customers). FINRA notes that, while it recognizes...

  9. 76 FR 76777 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-12-08

    ... identity of the securities to be delivered at settlement is not specified on the date of execution (``Trade... same as those that apply to members reporting transactions in corporate bonds and Agency Debt... corporate bond market.\\16\\ The correlation between various TBA CUSIPs is high, and the price of one...

  10. 78 FR 62862 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-10-22

    ... securities, municipal securities, and corporate debt securities. See id. Certain ATSs are excluded from the... daily summaries of its trading activities, including (1) the identity of each security for...

  11. 76 FR 46340 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-08-02

    ... June 11, 2009 (``FSI Letter''); letter from Sean C. Davy, Managing Director, Corporate Credit Markets... of provisions requiring display of the identity of clearing firms and other issues. In addition... account related to erroneous transactions, identity theft, or other potential problems.\\37\\ \\36\\...

  12. 78 FR 55322 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-09-10

    ... merger, acquisition or other corporate reorganization; providing venture capital, equity lines of credit....\\10\\ \\10\\ For example, members have noted that broker-dealers normally do not know the identity of...

  13. 76 FR 61124 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-10-03

    ... activity of its affiliates.\\5\\ The rule defines an ``affiliate'' of the member as any wholly owned... Immediate Effectiveness of Proposed Rule Change Relating to Aggregation of Activity of Affiliated Members... Rule Change FINRA is proposing to amend Rule 7630A (Aggregation of Activity of Affiliated...

  14. 75 FR 12584 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-03-16

    ... best possible manner, which will disadvantage retail customers.\\26\\ One commenter believed that the... lead to an increase in gaming practices.\\12\\ \\8\\ See ArcaEdge and TD Ameritrade. \\9\\ See Knight... practice of submitting locking or crossing quotations (and requiring reconciliation of locked/crossed...

  15. 76 FR 9386 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-02-17

    ... market-making desks where the member structures its order handling practices in NMS stocks to permit its... to ``work the order,'' the member has a clear responsibility to endeavor to obtain the best fill for... execute any order received from a customer in a manner that does not disadvantage the customer or place...

  16. 77 FR 5069 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-02-01

    ...\\ FINRA will continue its concerted communications campaign to ensure that the public (including retail investors) is well-informed with respect to the pending changes. See www.OTCBB.com August 1, 2011 news item... and equitable principles of trade, and, in general, to protect investors and the public...

  17. 75 FR 167 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-01-04

    ... request in relation to FINRA rules Rule 9551 (Failure to Comply with Public Communication Standards), Rule... investors who have been harmed); --Harmonize the remedy for an individual's failure to pay an arbitration..., Secretary, Commission, from Scott R. Shewan, President, Public Investors Arbitration Bar...

  18. 75 FR 61541 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-10-05

    ... would have the same meaning as FINRA Rule 5130.\\8\\ \\7\\ One commenter asked that hedge funds clearly be included in the proposal. See Regal. FINRA notes that hedge funds would be included where the beneficial... parties have an economic interest. \\20\\ One commenter asked that hedge funds clearly be included in...

  19. 75 FR 62911 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-10-13

    ... Securities Exchange Act Release No. 62655 (August 5, 2010), 75 FR 48731 (August 11, 2010). \\4\\ See Letter... that cannot be relocated to another financial institution, such as many limited partnership or hedge fund investments, FINRA is proposing new paragraph (b)(2) of the rule, which provides that the...

  20. 77 FR 33522 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-06-06

    ... running prohibitions to cover trading in an option, derivative, or other financial instrument overlying a... to all related financial instruments (e.g., stock options and futures, options futures, other... types of securities other than options and security futures, FINRA intends to make clear that...

  1. 75 FR 475 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-01-05

    ... Proposed Rule Change To Adopt FINRA Rule 2261 (Disclosure of Financial Condition) in the Consolidated FINRA... Financial Condition to Customers) and NASD Rule 2910 (Disclosure of Financial Condition to Other Members) as... 2270 and NASD Rule 2910, subject to certain amendments, into FINRA Rule 2261 (Disclosure of...

  2. 77 FR 8938 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-02-15

    ... to the Statement of Income (Loss) Page of FOCUS Reports February 9, 2012. I. Introduction On November... problems in several recent examinations and investigations, including fraud and sales practice abuses in... investigations, including fraud and sales practice abuses in Regulation D offerings.\\59\\ The Commission believes...

  3. 75 FR 34183 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2010-06-16

    ..., Secretary, Commission, dated June 3, 2010 (``ICI Letter''); Letter from Daniel Mathisson, Credit Suisse Securities (USA) LLC to Elizabeth M. Murphy, Secretary, Commission, dated June 3, 2010 (``Credit Suisse..., Accenture Letter, Angel Letter, Bean Letter, CCMP Letter, Credit Suisse Letter, IAG Letter, ICI Letter...

  4. 77 FR 20452 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-04-04

    ... behalf of Citigroup Global Markets, Inc., Credit Suisse Securities (USA) LLC, Goldman, Sachs & Co., JP... from Yoon-Young Lee, Wilmer Hale LLP, on behalf of Citigroup Global Markets, Inc., Credit Suisse...

  5. 76 FR 41537 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-07-14

    ... FINRA officers potentially exerting undue influence in FINRA proceedings. Although FINRA is not aware of any instances of former officers exerting undue influence in FINRA's disciplinary and similar forums... the appearance of any undue influence. \\10\\ See FINRA Rule 9141(b). \\11\\ Richard Acello, New York...

  6. 78 FR 73900 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-12-09

    ..., Secretary, Commission, dated September 25, 2013 (``FIF Letter''); and letter from Theodore R. Lazo, Managing... Elizabeth M. Murphy, Secretary, Commission, from Brant K. Brown, FINRA, dated December 2, 2013...

  7. 77 FR 56694 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-09-13

    ... Filing of Proposed Rule Change to Amend the Customer and Industry Codes of Arbitration Procedure Relating... Proposed Rule Change FINRA is proposing to amend the Customer and Industry Codes of Arbitration Procedure (collectively ``Codes''), to provide that when specified industry parties seek the appearance of witnesses or...

  8. 77 FR 55519 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2012-09-10

    ... instrument, even if the applicable customer-related transaction has not become public. \\23\\ See SIFMA Letter... letters on the proposed rule change,\\4\\ and a response to comments from FINRA.\\5\\ On August 30, 2012... Release No. 67079 (May 30, 2012), 77 FR 33522 (``Notice''). \\4\\ See Letters to Elizabeth M....

  9. 77 FR 4065 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-01-26

    ...''); Stuart J. Kaswell, Executive Vice President, Managed Funds Association, dated November 14, 2011 (``MFA...\\ \\15\\ ABA; MFA. Three commenters stated that the proposed rule change could significantly affect the ability of many issuers to raise capital.\\16\\ The ABA and MFA also stated that they believe that...

  10. 78 FR 72946 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-12-04

    ..., dated Sept. 30, 2013 (``MFA letter''). The letters are available on the Commission's Web site at http... letter and MFA letter. \\15\\ Id. Both commenters asked that FINRA eliminate the proposed condition that... aspect of the proposal.\\19\\ \\16\\ Id. \\17\\ Id. \\18\\ See MFA letter. \\19\\ See Cordium letter. As...

  11. 77 FR 26340 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-05-03

    ... concerning the adjustment of corporate actions for short interest reporting purposes. The text of the... corporate action occurs by the reporting settlement date designated by FINRA for such cycle (even if payment... corporate actions for short interest reporting purposes, FINRA amended its proposal to delete this aspect...

  12. 75 FR 36461 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-06-25

    ... an encryption method that meets industry standards for strong encryption; and (2) to provide FINRA staff with the confidential process or key regarding the encryption in a communication separate from the....215 (Security Measures for Data Collector that Accepts Payment Card; Use of Encryption; Liability...

  13. 78 FR 49313 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-08-13

    ... 4370(f) (Business Continuity and Emergency Contact Information), which requires a member to report to...), (c) and (e) (Business Continuity Plans and Emergency Contact Information) require a member to create, maintain and update a written business continuity plan and to disclose the elements of the plan...

  14. 76 FR 24942 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-05-03

    ... consists of the following fees: The Personnel Assessment (PA); the Gross Income Assessment (GIA); and the... period, FINRA has proposed the restructuring of both the GIA and the PA. For example, effective January 1, 2010, the GIA and PA were restructured to stabilize cash flows by shifting a greater portion of...

  15. 77 FR 54636 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-09-05

    ... assigned at any time during the life of the contract. European-style options can only be exercised or...)(A)(xxxii) to mean a ``long'' and ``short'' position in different call option series, different put... or instrument; (2) all ``long'' and ``short'' option contracts must be either all American-style...

  16. 77 FR 38692 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-06-28

    ... Immediate Effectiveness of Proposed Rule Change To Adjust Fees for Review of Advertising Material Filed With..., sales literature, and other such material filed with or submitted to FINRA's Advertising Regulation... additional staff to maintain the program's effectiveness and ensure reasonable turnaround times, particularly...

  17. 77 FR 3019 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Science.gov (United States)

    2012-01-20

    ... Transparency for Agency Pass-Through Mortgage-Backed Securities Traded TBA January 13, 2012. On November 22... transparency for agency pass-through mortgage-backed securities traded ``to be announced'' (``MBS TBA... From the Federal Register Online via the Government Publishing Office ] SECURITIES AND EXCHANGE...

  18. 77 FR 24748 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2012-04-25

    ... currently does not disseminate such information publicly.\\5\\ Agency Pass-Through Mortgage- Backed Securities...- Backed Securities Traded TBA April 18, 2012. I. Introduction On March 1, 2012, the Financial Industry...-Backed Securities (``MBS'') traded ``to be announced'' or ``TBA.'' The proposed rule change was published...

  19. 77 FR 23524 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-04-19

    ... Proposed Rule Change Relating to Post-Trade Transparency for Agency Pass-Through Mortgage-Backed Securities... Mortgage-Backed Securities traded in Specified Pool Transactions (``MBS Specified Pool transactions'') and... Security, Agency Pass-Through Mortgage-Backed Security, Specified Pool Transaction, Asset-Backed Security...

  20. 77 FR 65436 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2012-10-26

    ... proposed rule change relating to post-trade transparency for Agency Pass-Through Mortgage-Backed Securities....19b-4. \\3\\ The terms ``Asset-Backed Security,'' ``TBA,'' ``Agency Pass- Through Mortgage-Backed... regarding transactions in Agency Pass-Through Mortgage-Backed Securities traded TBA (``MBS TBA''), a type of...

  1. 78 FR 70602 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-11-26

    ... instruments from the term Asset- Backed Security: (i) Agency Pass-Through Mortgage-Backed Securities traded to... terms Agency Pass-Through Mortgage-Backed Security and To Be Announced (``TBA'') are defined... excludes: (i) An Agency Pass-Through Mortgage-Backed Security as defined in paragraph (v) traded To Be...

  2. 76 FR 65313 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-10-20

    ... Transactions in Agency Pass-Through Mortgage-Backed Securities Traded ``To Be Announced'' October 13, 2011... Security that is an Agency Pass-Through Mortgage-Backed Security traded ``to be announced'' and to... reporting fee for transactions in ABS, including Agency Pass-Through Mortgage-Backed Securities (``Agency...

  3. 77 FR 32703 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Science.gov (United States)

    2012-06-01

    ... Transparency for Agency Pass-Through Mortgage-Backed Securities Traded in Specified Pool Transactions and SBA-Backed Asset-Backed Securities Transactions May 25, 2012. On April 2, 2012, the Financial Industry...-Backed Securities traded in Specified Pool Transactions (``MBS SPT'') and Asset- ] Backed Securities...

  4. 77 FR 66908 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2012-11-07

    ... Transparency for Agency Pass-Through Mortgage-Backed Securities Traded in Specified Pool Transactions and SBA-Backed Asset-Backed Securities Transactions. The document contained a typographical error. FOR FURTHER...- Backed Securities Traded in Specified Pool Transactions and SBA-Backed Asset-Backed Securities...

  5. 78 FR 35078 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2013-06-11

    ... Mortgage Backed-Securities (``MBS'') and Asset-Backed Securities (``ABS'') backed by loans guaranteed as to... transaction is reported.\\4\\ \\4\\ The terms Agency Pass-Through Mortgage-Backed Security, Asset-Backed Security...-Backed Securities and SBA-Backed Asset-Backed Securities Traded in Specified Pool Transactions June 5...

  6. 77 FR 15827 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-03-16

    ... Proposed Rule Change Relating to Post-Trade Transparency for Agency Pass-Through Mortgage-Backed Securities...-Through Mortgage-Backed Securities that are traded to be announced (``TBA'') (``TBA transactions''); to... changes.\\3\\ \\3\\ The terms TRACE-Eligible Security, Agency Pass-Through Mortgage-Backed Security and TBA...

  7. 77 FR 56686 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-09-13

    ... Mortgage-Backed Securities Traded in Specified Pool Transactions and SBA-Backed Asset- Backed Securities... that are: (1) Agency Pass-Through Mortgage-Backed Securities traded in Specified Pool Transactions...\\ \\3\\ The terms TRACE-Eligible Security, Agency Pass-Through Mortgage-Backed Security, Specified Pool...

  8. 75 FR 32525 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-06-08

    ... disciplinary cases involving failures to pay arbitration awards and restitution.\\11\\ The legal underpinnings... can include payment plans), moving to vacate the award, or filing for bankruptcy. Three commenters...

  9. 75 FR 37488 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-06-29

    ... Pricing Increment for OTC Equity Securities) to impose restrictions on the display of quotes and orders... pricing increment under Rule 6434. \\12\\ 17 CFR 242.610(c). Fourth, FINRA proposes to adopt Rule 6460... the order not be displayed; (3) is an odd-lot order; (4) is a block size order, unless a customer...

  10. 76 FR 36586 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-06-22

    ... Officer, The Leaders Group, Inc./TLG Advisors, Inc., dated April 6, 2011 (``TLG''); Matthew J. Gavaghan... members' operations activities of such significance to require registration, qualification examination...

  11. 77 FR 55885 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-09-11

    ... Director's or member's firm or partnership. The proposal would amend the definition to exempt any services... cannot because of the definitions of Industry Member \\3\\ and Public Member \\4\\ in the FINRA Dispute Resolution By-Laws (By-Laws). \\3\\ See Dispute Resolution By-Laws, Article I(s) (Definitions-- Industry Member...

  12. 75 FR 17806 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-04-07

    ....\\20\\ \\20\\ The proposed definition of ``normal market hours'' is identical to the TRF rules, and the... members report secondary market transactions in non-exchange-listed direct participation program (``DPP... NMS stocks, as defined in SEC Rule 600(b) of Regulation NMS, effected otherwise than on an...

  13. 75 FR 7530 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-02-19

    ... securities'').\\6\\ In September 2008, the NASDAQ Stock Market (``NASDAQ'') ceased the operation of the PORTAL... requirements for restricted equity securities; update the definition of ``OTC Equity Security;'' and clarify... proposed rule change amends the definition of ``OTC Equity Security'' in the FINRA trade reporting rules...

  14. 77 FR 76113 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-12-26

    ... of Trade), 2020 (Use of Manipulative, Deceptive or Other Fraudulent Devices), 3310 (Anti-Money Laundering Compliance Program) and 4240 (Margin Requirements for Credit Default Swaps). See also paragraphs... is targeted and does not include, for instance, relief from the Act's antifraud and anti-manipulation...

  15. 78 FR 20708 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2013-04-05

    ... Manipulative, Deceptive or Other Fraudulent Devices), 3310 (Anti-Money Laundering Compliance Program) and 4240... include, for instance, relief from the Act's antifraud and anti-manipulation provisions. FINRA has noted...

  16. 76 FR 42755 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-07-19

    ... fraudulent devices); FINRA Rule 3310 (anti-money laundering program); and FINRA Rule 4240 (margin... antifraud and anti-manipulation provisions. FINRA notes that proposed new FINRA Rule 0180 is similarly...

  17. 76 FR 19155 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-04-06

    ...''); Leonard Steiner, Esq., dated August 16, 2010 (``Steiner comment''); Robert C. Port, Esq., Cohen Goldstein... (``Boliver comment''); Scott C. Ilgenfritz, Esq., Johnson, Pope, Bokor, Ruppel & Burns, LLP, dated September... Clinic, SIFMA, Boliver, and Ilgenfritz comments. \\8\\ See Lipner, Steiner, Port, McCauley, Nygaard, Gard...

  18. 77 FR 3515 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Instituting...

    Science.gov (United States)

    2012-01-24

    ... (``Shatto Letter''); Letter from Naphtali M. Hamlet, dated October 21, 2011 (``Hamlet Letter); Letter from... III, and Knight Letter II. \\22\\ See Shatto Letter. \\23\\ See Hamlet Letter. One commenter expressed the...

  19. 76 FR 70190 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2011-11-10

    ... October 20, 2011 (``Shatto Letter''); letter from Naphtali M. Hamlet, Investor, dated October 21, 2011 (``Hamlet Letter''); letter from Daniel Zinn, General Counsel, OTC Markets Group Inc., dated October 20... reported for public dissemination. \\12\\ See Shatto Letter; Hamlet Letter. \\13\\ See Shatto Letter. \\14\\ See...

  20. 77 FR 37458 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-06-21

    ... from Suzanne H. Shatto, dated October 20, 2011 (``Shatto Letter''); Letter from Naphtali M. Hamlet, dated October 21, 2011 (``Hamlet Letter); Letter from Daniel Zinn, General Counsel, OTC Markets Group... Shatto Letter. \\36\\ See Hamlet Letter. Knight expressed the view that the proposal could have the...

  1. 76 FR 61429 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-10-04

    ... Extraordinary Market Volatility) (i) To reflect changes to market-wide circuit breaker triggers for NMS stocks... single stock circuit breakers in a general market downturn cause the index calculation to become stale... Proposed Rule Change To Update Rule 6121 (Trading Halts Due to Extraordinary Market Volatility) and...

  2. 75 FR 6769 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-02-10

    ..., 2010; and Jill I. Gross, Director, The Investors Rights Clinic at Pace University Law School, dated... Dispute Resolution (``Director'') will select the hearing location closest to the customer's residence at... location is closer to the customer's residence, Hoboken,\\5\\ than FINRA's Newark, New Jersey hearing...

  3. 77 FR 70860 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-11-27

    ... the minimum dollar net capital requirement or two percent of combined aggregate debit items as shown in the Formula for Reserve Requirements pursuant to 17 CFR 240.15c3-3. The proposed rule change will... an ongoing basis the financial condition of firms. In the absence of this reporting...

  4. 78 FR 21449 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2013-04-10

    ..., Acting Director, St. John's University School of Law Securities Arbitration Clinic, dated Feb. 4, 2013...''); letter from Robert Savage, Visiting Assistant Clinical Professor, Florida International University... representatives and would be a positive step toward enhancing investors' perception of fairness in FINRA's...

  5. 78 FR 58580 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2013-09-24

    ... Rights Clinic, Pace University School of Law, dated July 11, 2013 (``Pace Law Letter''); Scott C...''); Christine Lazaro, Esq., Acting Director, and Pamela M. Albanese, Legal Intern, St. John's University School...-arbitrator case raised a perception that FINRA Dispute Resolution's forum was not fair to customers. In order...

  6. 75 FR 80556 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-12-22

    ... definition of ``direct participation program'' from former FINRA Rule 6642 to current FINRA Rule 6420.\\7\\ \\7...) of the Act,\\8\\ which requires, among other things, that FINRA rules must be designed to prevent... Commission's Internet comment form ( http://www.sec.gov/rules/sro.shtml ); or Send an e-mail to...

  7. 78 FR 8668 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2013-02-06

    ...-wide Circuit Breakers in NMS Stocks) January 31, 2013. Pursuant to Section 19(b)(1) of the Securities... operative date of FINRA Rule 6121.02 (Market-wide Circuit Breakers in NMS Stocks), which reflects changes to the methodology for triggering market-wide circuit breakers for NMS stocks.\\3\\ FINRA is delaying...

  8. 78 FR 4186 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2013-01-18

    ... provisions relating to securities offered or sold pursuant to crowdfunding.\\5\\ Intermediaries in transactions involving the offer or sale of securities for the account of others pursuant to the crowdfunding exemption...\\ In general, crowdfunding refers to the use of the Internet by small businesses to raise...

  9. 75 FR 29793 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-05-27

    ... amendment to FINRA Rule 3160 to reflect a change in FINRA's style convention when referencing federal... written communications relating to the proposed rule change between the Commission and any person,...

  10. 75 FR 51310 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-08-19

    ..., integrated change to customer care standards adopted at one time.\\53\\ \\51\\ Rex A. Staples, General Counsel... Proposed Rule Change To Adopt FINRA Rules 2090 (Know Your Customer) and 2111 (Suitability) in the... (Know Your Customer) and FINRA Rule 2111 (Suitability) as part of the Consolidated FINRA Rulebook....

  11. 75 FR 52562 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-08-26

    ..., integrated change to customer care standards adopted at one time.\\53\\ \\51\\ NASAA Letter, supra note 47. \\52... Proposed Rule Change To Adopt FINRA Rules 2090 (Know Your Customer) and 2111 (Suitability) in the... FINRA Rules 2090 (Know Your Customer) and 2111 (Suitability) in the Consolidated FINRA Rulebook...

  12. 78 FR 54502 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-09-04

    ... strategy with any other aggregation unit.\\6\\ It also provides that, at the time of each sale, each... a Proposed Rule Change Relating to Wash Sale Transactions and FINRA Rule 5210 (Publication of... emphasize that wash sale transactions are generally non-bona fide transactions and that members have...

  13. 75 FR 3768 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-01-22

    .... FINRA believes that by providing additional market data relating to ATS dark pools, the proposed rule change will increase market transparency of trading volumes within those ATS dark pools that choose to... within a FINRA member's alternative trading system (``ATS'') dark pool and reported to a FINRA...

  14. 75 FR 11972 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-03-12

    ... investors, market participants and other persons will have access to the ATS dark pool data on terms that... that are executed within a FINRA member's alternative trading system (``ATS'') dark pool and reported... ``dark pools'' of liquidity. FINRA proposes to define such dark pools to include an ATS that does...

  15. 75 FR 69481 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-11-12

    ..., parties in arbitration participate in selecting the arbitrators who serve on their cases. For customer claims of more than $100,000, the Customer Code currently provides for a three arbitrator panel \\3\\ comprised of a chair- qualified public arbitrator, \\4\\ a public arbitrator, \\5\\ and a non- public...

  16. 78 FR 11925 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2013-02-20

    ... public media, including any Web site, newspaper, magazine or other periodical, radio, television... the Commission's Internet comment form ( http://www.sec.gov/rules/sro.shtml ); or Send an email to... post all comments on the Commission's Internet Web site ( http://www.sec.gov/rules/sro.shtml ). Copies...

  17. 76 FR 82014 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-12-29

    ..., including any generally accessible Web site, newspaper, magazine or other periodical, radio, television...'s Internet comment form ( http://www.sec.gov/rules/sro.shtml ); or Send an email to rule-comments... on the Commission's Internet Web site ( http://www.sec.gov/rules/sro.shtml ). Copies of the...

  18. 77 FR 72899 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-12-06

    ...\\ which requires, among other things, that FINRA rules provide for the equitable allocation of reasonable... the Commission's Internet comment form ( http://www.sec.gov/rules/sro.shtml ); or Send an email to... post all comments on the Commission's Internet Web site ( http://www.sec.gov/rules/sro.shtml )....

  19. 75 FR 1672 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-01-12

    ... money from or lend money to his or her customer unless the firm has written procedures allowing such lending arrangements and (1) the customer is a member of the registered person's immediate family;\\7\\ (2) the customer is in the business of lending money; (3) the customer and the registered person are...

  20. 77 FR 14848 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-03-13

    ... Commission actions,\\6\\ is intended to address concerns arising from counterparty credit risk posed by CDS, including, among other things, risks to the financial system arising from credit risk resulting from bilateral CDS transactions and from a concentration of credit risk to a central counterparty that clears...

  1. 75 FR 8770 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-02-25

    ... Consolidation Process). \\4\\ For convenience, the Incorporated NYSE Rules are referred to as the ``NYSE Rules... customer without requiring the member to send a periodic customer account statement to the individual as otherwise generally required, provided the following conditions are satisfied: (1) The customer...

  2. 75 FR 74759 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-12-01

    ... Consolidation Process). \\4\\ For convenience, the Incorporated NYSE Rules are referred to as the ``NYSE Rules... customer accounts also apply to any member that, operating pursuant to the exemptive provisions of SEA Rule 15c3-3(k)(2)(i), either clears customer transactions pursuant to such exemptive provisions or...

  3. 75 FR 17456 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-04-06

    ... Information Notice, March 12, 2008 (Rulebook Consolidation Process). \\5\\ For convenience, the Incorporated... provided that such sales might be effected on behalf of the customer without requiring the member to send a periodic customer account statement to the individual as otherwise generally required, provided...

  4. 78 FR 29190 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving the...

    Science.gov (United States)

    2013-05-17

    ...), 78 FR 9963 (``Notice''). \\5\\ See Letter from Christopher Nagy, President, KOR Trading LLC to... as practicable and would violate the rule if they withhold trade reports, e.g., by programming their... or service bureau, or unusual market conditions, such as extreme volatility in a security, or in...

  5. 78 FR 9963 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-02-12

    ... programming their systems to delay reporting until the last permissible second.\\6\\ \\4\\ See, e.g., FINRA Rules... unusual market conditions, such as extreme volatility in a security, or in the market as a whole.'' \\7... prohibits members from purposely withholding trade reports, e.g., by programming their systems to...

  6. 78 FR 16341 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2013-03-14

    ... commensurate with the risks of the portfolio based on correlations in a member's cleared CDS positions... security-based swaps (``CDS'') held in an account subject to an approved portfolio margining program, the amount of margin determined by the member's portfolio margin methodology, subject to specified...

  7. 76 FR 26779 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-05-09

    ... concept proposal to require members, at or prior to commencing a business relationship with a retail... open-end management investment companies or unit investment trusts (``UITs'') that differ from... company'' and ``closed-end company.'' \\15\\ \\15\\ See Sections 4(3) and 5(a) of the Investment Company Act...

  8. 76 FR 45883 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-08-01

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE... for individuals who are registered or seeking registration with FINRA. FINRA also delivers... vendors and degrade the efficiency of test center resource utilization. To discourage such behavior,...

  9. 78 FR 5532 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2013-01-25

    ...). \\5\\ The specified events and customer complaint information must be electronically reported to FINRA... not extend to the reporting of quarterly statistical and summary customer complaint information under... Action; (3) Civil Judicial; and (4) Customer Complaint/Arbitration/Civil Litigation. \\8\\ FINRA Rules...

  10. 75 FR 41254 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-07-15

    ... reported customer complaint, arbitration or litigation is less than ten years old; and (iii) the person has... are customer complaints that were reported on a uniform registration form that are more than two years old and that have not been settled or adjudicated and customer complaints, arbitrations,...

  11. 75 FR 69508 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filings...

    Science.gov (United States)

    2010-11-12

    ... Supplementary Material .08 to clarify a member's reporting obligations regarding customer complaints pursuant to... written customer complaints pursuant to proposed FINRA Rule 4530(d), regardless of whether such...\\ and (3) any written customer complaint reported under proposed FINRA Rule 4530(a)(1)(B) must also...

  12. 75 FR 21064 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-04-22

    ...) make publicly available in BrokerCheck all historic customer complaints that were archived after the...., reportable customer complaints or Historic Complaints, criminal charges, terminations, bankruptcies, liens..., Historic Complaints are customer complaints that were reported on a uniform registration form that are...

  13. 76 FR 5850 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2011-02-02

    ... (Records of Written Customer Complaints), NASD Rule 3110(f) (Requirements When Using Predispute Arbitration... of written customer complaints at each office of supervisory jurisdiction (``OSJ''). NASD Rule 3110(e... 4513. The proposed rule change also would clarify that the obligation to keep customer...

  14. 75 FR 47863 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-08-09

    ...) and quarterly statistical and summary information regarding written customer complaints. FINRA uses...)) and quarterly statistical and summary information regarding written customer complaints (FINRA Rule... liable for the aggregate amount); \\7\\ \\7\\ See Notice to Members 96-85 (December 1996) (Customer...

  15. 78 FR 40792 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-07-08

    ... (Customer Complaints), and Incorporated NYSE Rule 342.21 (Trade Review and Investigation); (3) replace NASD... representatives' transactions and correspondence and Incorporated NYSE Rule 401A (Customer Complaints) relating to the review of customer complaints. In addition, proposed supplementary material, which is discussed...

  16. 75 FR 45685 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-08-03

    ... to produce Forms RE-3, U-4, and U-5, including all amendments, customer complaints identified in the forms, and customer complaints of a similar nature against the associated persons handling the accounts... information about prior customer ] complaints. FINRA would narrow production of these forms to the...

  17. 76 FR 38245 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-06-29

    ... Reasonable Review), Incorporated NYSE Rule 401A (Customer Complaints), and Incorporated NYSE Rule 342.21... representatives and Incorporated NYSE Rule 401A (Customer Complaints) relating to the review of customer... handle in ] accordance with the firm's procedures: Customer complaints, instructions, and funds...

  18. 75 FR 67155 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-11-01

    ...) as FINRA Rule 4513 (Records of Written Customer Complaints), NASD Rule 3110(f) (Requirements When... redundant and others are outdated. c. Records of Written Customer Complaints (Proposed FINRA Rule 4513) NASD Rule 3110(d) addresses a member's obligation to preserve records of written customer complaints at...

  19. 77 FR 27262 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2012-05-09

    ... letter from Jill I. Gross, Director, Edward Pekarek, Assistant Director, and Genavieve Shingle, Student... forum, and by improving the environment for pro bono legal services organizations to help more...

  20. 77 FR 31677 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2012-05-29

    ... Jill I. Gross, Director; Edward Pekarek, Assistant Director, and Genavieve Shingle, Student Intern... bono mediator, or a mediator who is willing to accept a reduced fee. The letter expressed concern that... mediations on a pro bono basis for parties of limited means; and (4) every October, FINRA hosts...

  1. 75 FR 17810 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-04-07

    ... which the member is identified as a party to the trade; (2) whether the transaction is ``media... contribute to achievement of the cap. However, if a member is eligible for a cap based on media trade reports... always be equal to the daily average number of Media/Executing Party trades needed to qualify for a cap...

  2. 78 FR 62722 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2013-10-22

    ...) Underlies a standardized index option; or (B) Satisfies the following criteria: (i) The basket or index...''), as further described below, will not be required to be delivered to customers effecting transactions... short calls) that can be held or written by a member, a person associated with a member, a customer or...

  3. 78 FR 5542 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-01-25

    ... investment banking or securities business maintained by or on behalf of any person associated with a member... on the professional background, business practices, and conduct of FINRA- member firms and their... code, and increase the educational content on BrokerCheck. In light of the Study's ``intermediate-term...

  4. 76 FR 25397 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2011-05-04

    ...'') candidate in a contested election. In recent years, FINRA has witnessed a decline in the number of eligible... process. FINRA believes this decline is due to a number of perceived problems which FINRA seeks to address... the voting process a popularity contest rather than a selection by peers based on proven track...

  5. 75 FR 58007 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-09-23

    ... of Arbitration Procedure for Customer Disputes (``Customer Code'') and by creating new Rule 12902(e... 12104(b) of the Customer Code and Rule 13104(b) of the Industry Code (together, Codes), state, in... come to the arbitrator's attention during and in connection with the arbitration only at the...

  6. 78 FR 44997 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-07-25

    ... defined in FINRA Rule 6710(l) and Asset-Backed Securities (``ABS'') as defined in FINRA Rule 6710(m). The... transactions in corporate bonds, Agency Debt Securities (as defined in FINRA Rule 6710(l)) and Asset-Backed...), including amendments that will become effective on July 22, 2013, Asset-Backed Securities transactions...

  7. 77 FR 74896 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-12-18

    ... Proposed Rule Change To Require Members To Report the Factor to TRACE in Asset-Backed Security Transactions (Except an Asset-Backed Security Traded TBA), in the Limited Instances When Members Effect Such... Asset-Backed Security (except an Asset-Backed Security traded To Be Announced), in the limited instances...

  8. 78 FR 4917 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2013-01-23

    ... trade journal files. These files are available for Asset-Backed Securities transactions and separately... was a party that were reported on that date either in Asset-Backed Securities or Corporate/Agency Debt... subscriber to obtain reports for Asset-Backed Securities or Corporate/Agency Debt Securities data for...

  9. 76 FR 4966 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-01-27

    ... Proposed Rule Change Relating to the Trading Activity Fee Rate for Transactions in Asset-Backed Securities... Activity Fee (``TAF'') for transactions in Asset-Backed Securities. The text of the proposed rule change is... to the TRACE reporting requirements to include transactions in Asset-Backed Securities.\\6\\ Under the...

  10. 76 FR 21084 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Science.gov (United States)

    2011-04-14

    ... Asset-Backed Securities April 8, 2011. I. Introduction On March 3, 2011, the Financial Industry... for the reporting of Asset-Backed Securities transactions to TRACE.\\3\\ The proposed rule change was... Rule 6700 Series to define Asset- Backed Securities as TRACE-Eligible Securities and to require members...

  11. 78 FR 56251 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2013-09-12

    ... certain Asset-Backed Securities, which information FINRA previously collected but did not disseminate. See... FR 65436 (October 26, 2012) (approving SR-FINRA-2012-042). The term ``Asset-Backed Security'' is... and certain Asset-Backed Securities are currently disseminated. But there would be no additional...

  12. 76 FR 25385 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2011-05-04

    ... Approval of a Proposed Rule Change Relating to TRACE Reporting of Asset-Backed Securities April 28, 2011. I... Reporting and Compliance Engine (``TRACE'') reporting of Asset-Backed Securities. The proposed rule change... the FINRA Rule 6700 Series to define ``Asset-Backed Securities'' as TRACE-Eligible Securities, thereby...

  13. 76 FR 15352 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-03-21

    ... Proposed Rule Change Relating to TRACE Reporting of Asset-Backed Securities March 16, 2011. Pursuant to... Security,'' ``Asset- Backed Security'' and ``TRACE System Hours''; to add a defined term, ``Securitizer...'') for reporting Asset-Backed Securities transactions; (C) to consolidate reporting requirements for...

  14. 76 FR 72736 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2011-11-25

    ...-Eligible Securities other than Asset-Backed Securities are required to be reported. The proposed rule..., transactions only in TRACE-Eligible Securities that are Asset-Backed Securities are processed on the MPP.\\6... substantially similar to those that currently apply to transactions in Asset-Backed Securities and are described...

  15. 75 FR 22670 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-04-29

    ...- FINRA-2009-065) (hereinafter, ``SEC Order Approving TRACE Expansion--Asset-Backed Securities''). The... Compliance Engine (``TRACE'') to designate asset-backed securities, mortgage-backed securities and other similar securities (collectively, ``Asset-Backed Securities'') as eligible for TRACE, and to establish...

  16. 78 FR 15790 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2013-03-12

    ... Involving Asset-Backed Security Transactions March 5, 2013. I. Introduction On November 29, 2012, the... in an Asset-Backed Security ``(ABS'') (except ABS traded To Be Announced (``TBA'')), in the limited... CFR 240.19b-4. \\3\\ The terms ``Asset-Backed Security,'' ``To Be Announced,'' and ``Factor'' are...

  17. 76 FR 13248 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2011-03-10

    ... transactions in Asset-Backed Securities. The proposed rule change was published for comment in the Federal... calculating the TAF \\4\\ for transactions in Asset-Backed Securities.\\5\\ The TAF is one of the member... Commission approved a proposed rule change that generally makes transactions in Asset-Backed Securities...

  18. 77 FR 74249 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-12-13

    ... for Asset-Backed Securities transactions as well as for corporate bonds and Agency Debt Securities (``Corporate/Agency Debt Securities'').\\3\\ The Asset-Backed Securities trade journal files are separate from the Corporate/Agency Debt Securities trade journal files. \\3\\ Transactions in Asset-Backed Securities...

  19. 75 FR 68654 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-11-08

    ... Expansion--Asset-Backed Securities''). The proposed rule change would not make any new changes to the text...-backed securities, mortgage-backed securities and other similar securities (collectively, ``Asset-Backed... Security'' and ``TRACE- Eligible Security'' to include Asset-Backed Securities as TRACE- Eligible...

  20. 76 FR 62128 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-10-06

    ... reporting a transaction in a TRACE-Eligible Security, other than a transaction in an Asset-Backed Security... Currently, TRACE-Eligible Securities that are Asset-Backed Securities are processed on FINRA's enhanced... currently apply to transactions in Asset-Backed Securities, and will simplify reporting a ] transaction...