Benefit vs. risk: how FDA approves new drugs. (includes related articles on drug review glossary, evolution of drug law, review priorities, and a special system for OTC drugs) (special report) From: FDA Consumer | Date: December 1, 1987| Author: Farley, Dixie | COPYRIGHT 1987 U.S. Government Printing Office. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group.Copyright information

Benefit Vs. Risk: How FDA Approves New Drugs

Under current law, all new drugs need proof that they are effective, as well as safe, before they can be approved for marketing. But it's important to realize that no drug is absolutely safe. There is always some risk of an adverse reaction. It's when the benefits outweigh the risks that FDA considers a drug safe enough to approve.

In fact, it was only 25 years ago that U.S. drug law first embraced the idea of r...

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