A Guide to Drug Safety Terms at FDA

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Guide to Drug Safety Terms at FDA

http://www.fda.gov/consumer/updates/drugterms041108.html

The Food and Drug

Administration (FDA) approves a drug for marketing after determining that the

drug's benefits of use outweigh the risks for the condition that the drug will

treat. But even with a rigorous evaluation process, some safety problems

surface only after a drug has been on the market and has been used in a broader

population. This guide offers descriptions of some of the drug safety terms

commonly used by FDA throughout the life cycle of a drug.

On this page:

FDA Review

Taking Medication

Monitoring After Approval

Removal from the Market

Types of Safety Announcements

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Shari Ferbert

President, AFFTER

Advocates for Fibromyalgia Funding,

Treatment, Education and Research

www.affter.org