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Guidance Documents/Guidance-Document/Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act: Guidance for Industry

Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act: Guidance for Industry

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

November 21, 2001

April 24, 2020

Center for Drug Evaluation and Research

5d11a441-b244-476c-b428-3563a82f2f80

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