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U.S. Department of Health and Human Services


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Advances in FDA's Safety Program for Marketed Drugs

Premarket Safety Review and Marketed Drug Safety are Equal Priorities at the Center for Drug Evaluation and Research


In a 21-page drug safety report (below, left), the FDA describes actions the Center for Drug Evaluation and Research (CDER) has taken in recent years to enhance the quality, accountability, and timeliness of its postmarket drug safety decisions. 

These actions, including the development of important new scientific tools to enhance detection of potential drug safety issues that occur once a drug is on the market, are summarized in an 8-page highlights document (center).  

Accompanying these documents is the report titled, Regulatory Science in Action (right), which highlights several examples of research performed by CDER scientists that support regulatory decision making regarding drug safety and manufacturing quality.



image of cover of drug safety report
Drug Safety Report
(PDF - 188KB)
image of cover of drug safety highlights report

Drug Safety Highlights
(PDF - 5.84MB)

 image of cover of Regulatory Science In Action

Safety Science & Research Report
(PDF - 17.6MB)