Drugs

Postmarketing Safety Evaluation of New Molecular Entities: Final Report

[10/15/2009]
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 below.

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.

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 (PDF - 433KB), 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 final report as well as completed reviews related to the apomorphine, aripiprazole, and duloxetine evaluations. There are no reviews related to the ranolazine and rasagaline evaluations because they did not identify issues that required formal follow-up reviews.