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Guidance Documents/Guidance-Document/General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products

General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

September 7, 2022

April 11, 2024

Center for Drug Evaluation and Research

764daa65-55f6-4702-b131-6e18ebf48434

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