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Post-Marketing Safety Evaluation of New Molecular Entities (NMEs): Progress Report
In January, 2007, the Office of Surveillance and Epidemiology and the Office of New Drugs in the Center for Drug Evaluation and Research initiated the “NME Post-Marketing Safety Evaluation Pilot Program.” 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 purpose of the pilot program is to determine the value of such a systematic review and to inform a decision on whether such reviews should be regularly conducted for all, or a specified subset of, NMEs. The pilot program is also expected to provide valuable information about the required resources and appropriate methods for conducting such a systematic evaluation.
FDA has completed a review of two drugs under the pilot program and has prepared a report on progress to date.
This pilot program also responds to a recommendation in the Institute of Medicine (IOM) report, "The Future of Drug Safety: Promoting and Protecting the Health of the Public," September 2006, recommendation 5.4:
"The committee recommends that FDA evaluate all new data on new molecular entities no later than 5 years after approval. . ."
In its response to the IOM report, FDA introduced our plans to conduct a pilot program, beginning in 2007, to assess the utility of routine postmarketing evaluations of new molecular entities.
This website includes the progress report as well as completed reviews related to the duloxetine evaluation. There are no reviews related to the ranolazine evaluation because it did not identify issues that required a formal follow-up review.
- New Molecular Entity (NME) Post-Marketing Safety Evaluation Pilot Program Progress Report [HTML] [PDF] (March 18, 2008)
- Duloxetine Reviews
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Date created: March 18, 2008
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