``Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use''; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use.'' FDA intends to consider, for licensure of commercially-produced fibrin sealants, data from pivotal studies in which the primary endpoint is hemostasis effectiveness. This document is intended to provide guidance to manufacturers of fibrin sealant products for the design of clinical trials intended to support licensure.