About Clinical Trials and the FDA

From: Helen Dynda (olddad66@runestone.net)
Tue Apr 30 20:09:00 2002


Clinical Trials and the FDA

http://www.womenssurgerygroup.com/conditions/Adhesions/clinicalresearch.asp

This is a primer that every woman considering participation in an FDA-approved clinical trial should read and understand.

The FDA, short for Food and Drug Administration, is the government agency responsible for ensuring the health and safety of consumers in the areas of drugs, biologics, food, cosmetic products, and medical devices. It is the agency's mission to ensure that these products are safe, effective, and are produced under sanitary conditions. In addition, all product packaging and labeling should be truthful, informative, and not deceptive in any way.

The FDA: A Short History

The Clinical Trial Process

Phase 1

Phase 2

Phase 3

Phase 4


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