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Guidance Documents/Guidance-Document/E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population

E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

April 11, 2018

April 11, 2024

Center for Drug Evaluation and Research

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