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Health / Pharmaceuticals policy / Pharmacology / Food law / Structured Product Labeling / New Drug Application / Prescription Drug User Fee Act / Title 21 of the Code of Federal Regulations / Pharmaceutical industry / Medicine / Food and Drug Administration / Pharmaceutical sciences


SOPP 8412: Review of Product Labeling Version # 4 Effective Date: April 2, 2012 I. Purpose This SOPP outlines the general operating procedures for Center for Biologics Evaluation and Research (CBER) staff to process draf
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