FDA considering elimination of ELA for "well-characterized" biologics; guidance on pilot facilities.

CBER CONTEMPLATING ELIMINATION OF ELA FOR 39424"WELL-CHARACTERIZED" BIOLOGICS, FDA reported in a July 11 Federal Register notice announcing a guidance on the use of pilot manufacturing facilities for marketing approval of biologics. "The agency is currently considering changing its procedures to eliminate the requirement for a separate establishment license for certain well-defined classes of biologic products," the notice states. "Because of recent scientific advances, both in methods of manufacture and in methods of analysis, some products developed through biotechnology can be characterized in ways not historically considered possible," FDA explained. "Thus, the agency is considering allowing `biotech' products that are well characterized to be regulated under a single application."