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FDA Guidance for Industry Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, ,

Document Type:
Guidance for Industry
This document outlines the agency's current position with regard to clinical data used to support licensure of safe and effective commercially-produced fibrin sealants in the United States.

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