CBER to propose rule on reporting biologics manufacturing errors and accidents.
Executive Summary
FDA BIOLOGICS MANUFACTURING ERROR/ACCIDENT REPORTING REQUIREMENTS will be outlined in a proposed rule for comment due out of the agency in the next two to three months. Addressing a PDA/FDA meeting in Bethesda, Md. Oct. 1, CBER Division of Inspection and Surveillance Reporting of Errors and Accidents Director Boyd Fogle advised manufacturers of traditional biologic products, in vitro diagnostics, vaccines and plasma derivatives to "be aware of this proposal." The proposed regulation, 21 CFR 600.14, has received significant attention by blood products manufacturers but has been largely overlooked by traditional biologics manufacturers.