How have the FDA policies on enrollment of special populations changed?


On July 22, 1993, the FDA published the Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs, in the Federal Register [58 FR 39406]. The guideline was developed to ensure that the drug development process provides adequate information about the effects of drugs and biological products in women.

On December 13, 1994, FDA published a final rule on the labeling of prescription drugs for pediatric populations [59 FR 64240]. The rule encourages sponsors to include pediatric subjects in clinical trials so that more complete information about the use of drugs and biological products in the pediatric population can be developed.

About the Author
Proxima CRO Team
Stephanie Mull
Director of Project Management

Stephanie has over 20 years of clinical research experience working from the site, CRO and sponsor perspectives. She graduated Summa Cum Laude from Concordia University in St. Paul, MN, with a degree in Natural Science - biology and math.

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