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Guidance Documents/Guidance-Document/Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

April 12, 2011

May 12, 2021

Center for Drug Evaluation and Research

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