Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use Guidance for Industry May 1999

GUIDANCE DOCUMENT

• Docket Number: FDA-1997-D-0186
• Issued by: Center for Biologics Evaluation and Research

This document pertains to commercially-produced fibrin sealants composed of purified, virus-inactivated/removed human fibrinogen and human or bovine thrombin, with or without added components such as virus-inactivated/removed human factor XIII and/or aprotinin. A number of such products are currently available in Europe and Canada as hemostasis agents. Although manufacturers and clinicians in the United States have been actively engaged in the development and testing of fibrin sealants, only one fibrin sealant product has been licensed in this country. 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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