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Postmarketing Safety Evaluation of New Molecular Entities: Final Report

FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

The Office of Surveillance and Epidemiology and the Office of New Drugs in the Center for Drug Evaluation and Research (CDER) have completed the “NME Postmarketing Safety Evaluation Pilot Program” that began in January, 2007, and the final report is available.

In this pilot program, CDER undertook the systematic and collaborative review of the safety profiles of selected approved new molecular entities that have been marketed for varying lengths of time.  New molecular entities (NMEs) are drugs that include an active ingredient that has not previously been approved for marketing in the United States in any form.  The pilot program determined the value of such a systematic review.  As described in the final report, the pilot program also provided valuable information about the required resources and appropriate methods for conducting such a systematic evaluation.

For more information, please visit: New Molecular Entities



October 30, 2009 - Posted by | 1

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