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Pharmaceuticals policy / Medicine / Prescription Drug User Fee Act / New Drug Application / Biosimilar / Food and Drug Administration / Pharmaceutical sciences / Pharmacology


SOPP 8402: Designation of Amendments as Major Version #4 Effective Date: October 1, 2012 I. Purpose This Standard Operating Policy and Procedure (SOPP) describes the policy and procedures for
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biosimilar biological product applications / biological product / biological product applications / biological products / manufacturing / Web page B. Web / license applications / biosimilar biological products / fee products / manufacturing supplements / /

MusicGroup

Ph.D. / /

Organization

PDUFA V / FDA / C. Review Committee / Center for Biologics Evaluation and Research / Application Policy Task Force / Review Committee / /

Person

Robert A. Yetter / B. Conley Len Wilson Approval / /

Position

Major / Chair / Director to the Division / Director to Division / Responsibilities A. Product Office Regulatory Project Manager / Consultant / Director G. If Division / D. Division Director / Director 5 H. If Division / Director Division / Division Director / as appropriate / forward to Division / RPM/Chair / /

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