Status of postmarketing studies to be posted
The FDA has announced two measures to inform the public about the status of manufacturers’ commitments to carry out further clinical studies following the FDA’s approval of certain drugs and biological products.
One of the measures, the publication of the FDA’s first annual Federal Register (FR) report on these postmarketing studies, covers commitments that are required by the FDA as well as those voluntarily accepted by the manufacturers. In addition to the FR report, which is mandated by the FDA Modernization Act of 1997, the FDA is posting on its web site a searchable database with most of the same information (www.fda. gov/cder/pmc).
The database includes open postmarketing study commitments that have been made with the FDA’s Center for Biologics Evaluation and Research, and commitments concluded with the Center for Drug Evaluation and Research since Jan. 1, 1991. Both the FR notice and the web site list study commitments addressing clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology. Not included are certain other postmarketing commitments, such as those concerning chemistry, manufacturing, and controls, and there is no listing of proprietary information.
The web site, which lists only commitments that have been reviewed by the FDA for accuracy, will be updated with new postmarketing commitments each July, October, January, and April. Additional information about this site is available on the search page and in "Frequently Asked Questions (FAQs)."
The FDA has announced two measures to inform the public about the status of manufacturers commitments to carry out further clinical studies following the FDAs approval of certain drugs and biological products.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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