United States of America. The Food and Drug Administration has announced the availability of a guidance document entitled “Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use”. The FDA intends to consider, for licensing of commercially- produced fibrin sealants, data from pivotal studies in which the primary endpoint is haemostasis effectiveness.
Copies of the draft guidance are available from the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), 1401 Rockville Pike, Rockville MD 20852-1448, USA (with one self-addressed adhesive label) or from the Internet at: http://www.fda.gov/cber/guidelines.htm.
Reference: Federal Register 64(97): 27583-4 (1999).