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

概要

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use.'' After reviewing recent experience with fibrin sealant products in clinical studies conducted under Investigational New Drug (IND) regulations, the agency is proposing to accept applications for licensure of fibrin sealant products based on evidence from pivotal studies in which the primary endpoint is hemostasis effectiveness. As in the past, other endpoints such as wound healing or tissue sealing may serve as primary endpoints for pivotal studies, depending on the nature of the indications sought. This draft document will provide guidance to manufacturers of fibrin sealant products for the design of clinical trials intended to support licensure.