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Postmarketing Study Commitments Search for Postmarketing Study Commitments This Web site is intended to provide information to the public on postmarketing study commitments, also called phase 4 commitments. Postmarketing study commitments are studies — required of or agreed to by a sponsor — that are conducted after FDA has approved a product for marketing (e.g., studies requiring the sponsor to demonstrate clinical benefit of a product following accelerated approval). FDA uses postmarketing study commitments to gather additional information about a product's safety, efficacy, or optimal use. Agreements with sponsors to conduct postmarketing studies can be reached either before or after FDA has granted approval to a sponsor to market a product. The Food and Drug Administration Modernization Act of 1997 ("the Modernization Act") became law on November 21, 1997. Section 130(a) of Title I of the Modernization Act added a new provision (section 506B) on postmarketing studies to the Federal Food, Drug, and Cosmetic Act 356b ("the Act") (21 U.S.C. 356b). This new provision requires sponsors of approved drugs and biological products to report to FDA annually on the progress of their postmarketing study commitments. In addition, FDA was required to do the following:
The Agency has made good progress in implementing the postmarketing studies requirements in section 506B of the Act. Regulations A proposed rule on postmarketing study commitments was published on
December 1, 1999 (64 FR 67207). After receiving and considering public
comments, the final rule
[optional format: PDF As a complement to the final rule, the Agency also issued in April 2001 a draft guidance for industry to describe in greater detail the content, format, and timing of the postmarketing study reports. Once FDA has considered comments submitted to the docket on the draft guidance, the Agency will issue a final version of the guidance. Report to Congress The Report to Congress discusses the background of and need for the postmarketing study commitment effort and contains (1) a summary of the reports submitted by sponsors under section 506B, (2) an evaluation of the performance of sponsors in fulfilling the agreements, (3) an evaluation of the timeliness of FDA's review of the postmarketing studies, and (4) legislative recommendations regarding postmarketing studies. Annual Report in the Federal Register Section 506B required FDA to publish annually a notice in the Federal Register containing information on the performance of postmarketing commitments. The annual notice is intended to summarize the information in the postmarketing study commitments database. Commitments containing proprietary information (e.g., those to evaluate chemistry or manufacturing and control issues) are not included on the Web site. Note that the numbers that publish in the annual Federal Register notice cannot be compared to the numbers resulting from searches of the database on the Web site. The annual Federal Register notice incorporates totals for all postmarketing study commitments in the Agency database. The information in the Federal Register will be updated annually, whereas the numbers on the Web site will be updated quarterly.
The Web Site The Web site contains the basic information that FDA committed to make available to the public. The information currently available to search includes only postmarketing study commitments that have been reviewed for accuracy. This site does not include commitments containing proprietary information. The Web site will be updated quarterly (in July, October, January, and April), at which time additional commitments will be added and the status of existing commitments updated. More details about the specific information that is included on the site are provided on the search page and as part of the "Frequently Asked Questions (FAQ)." If you have any questions or comments related to this Web site, please send them to the Postmarketing Study Commitment Coordinator at pmcweb@cder.fda.gov.
Search for Postmarketing Study Commitments
Date created: May 23, 2003 ; Last Updated: October 28, 2004 |
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was published on October 30, 2000 (65 FR 64607). In
the preamble to the proposed and final rules, FDA announced its intention
to make basic information about the status of each postmarketing study
commitment available to the public on the Internet. The Agency has
developed and is making available on this Web site a searchable database
of information on postmarketing studies for drugs and biological products.
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