Zdrowie i gospodarka · 27/01/1999

Blood Standards; Pilot Program for Gamma Irradiated Blood and Blood Components and Draft ``Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing;'' Availability

The Food and Drug Administration (FDA) is announcing its intent to establish a pilot program for licensed blood product manufacturers seeking to market irradiated blood components in interstate commerce. FDA is also announcing the availability for public comment of a draft guidance document entitled ``Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing.'' FDA is proposing a pilot program that would allow a manufacturer to self-certify conformance to specific criteria as a substitute for the Center for Biologics Evaluation and Research (CBER) review of information submitted in a biologics license application (BLA) supplement filing. Instead of submitting a BLA supplement with supporting operating procedures and data derived from validation and quality control testing, the manufacturer would submit an application form (FDA Form 356h), a self-certification statement that provides that the manufacturer is in compliance with all applicable FDA regulations and meets the criteria for gamma irradiated blood and blood components set forth in the draft guidance document entitled ``Guidance for Industry: Gamma Irradiation of Blood and Blood Co