Fibrin sealant final guidance
This article was originally published in The Gray Sheet
Executive Summary
Data from representative surgical procedures can support FDA approval for an indication covering a group of surgical procedures, according to the May 20 final document. Inclusion of the statement comes in response to a comment received by the agency pertaining to a January 1998 draft guidance, "Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use" ("The Gray Sheet" Feb. 16, 1998, I&W-9)