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Guidance Documents/Guidance-Document/Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and Format

Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and Format

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

December 10, 2014

April 27, 2020

Center for Drug Evaluation and Research

91c267ae-e99d-4508-b31c-721b7da25d2b

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