White Papers for Food and Drug Administration (FDA)

Improving Public Health Through Human Drugs

Center for Drug Evaluation and Research

Americans are rightly concerned about the safety of their drugs. Too many suffer from unexpected and unpreventable adverse events from the medicines they need. Some have worried about “dangerous” drugs, while others have worried that an “overemphasis” on safety will delay developing new therapies. The most important concern for many Americans, however, has been the gap between the time a safety issue emerges and the time we know enough to make a regulatory decision.

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