Regulatory Issues

FDA proposes steps to assure the safety, efficacy of some unapproved medicines

Published in Medical Letter on the CDC and FDA, November 16th, 2003

The U.S. Food and Drug Administration (FDA) has proposed new steps to assure the safety and efficacy of certain unapproved but widely marketed medicines. The proposal aims to make sure that patients can be confident that the products will work as labeled, without creating circumstances in which valuable treatments would not be available for a health problem.

These unapproved drugs include medicines that were developed and marketed before modern standards for drug approval were established. The Food, Drug, and Cosmetic Act generally requires that drugs marketed in the United States be shown to be both safe and effective. Although the unapproved drugs are required by law...

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Source: Medical Letter on the CDC and FDA (2003-11-16)

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