Guidance for Industry Postmarketing Studies and Clinical Trials

Guidance for Industry Postmarketing Studies and Clinical Trials —
Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
April 2011
Drug Safety
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM172001.pdf