FDA Releases Draft Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use

Summary

The Food and Drug Administration (FDA) has released a draft document outlining the requirements for efficacy studies to support the marketing of fibrin sealant products. The document proposes that manufacturers submit evidence from pivotal studies demonstrating the effectiveness of hemostasis, with other endpoints such as wound healing or tissue sealing also considered.