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Guidance Documents/Guidance-Document/Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway

Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

February 4, 2019

April 24, 2020

Center for Drug Evaluation and Research

53afccba-4a69-4547-878f-b1a1b9a1e7b9

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