Zdrowie i gospodarka · 15/03/2000

Blood Standards; Pilot Program for Licensing Gamma Irradiated Blood and Blood Components and “Guidance for Industry: Gamma Irradiation of Blood and Blood Components;” Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled "Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program For Licensing," dated February 2000. FDA is also announcing the establishment of a pilot program for licensed blood product manufacturers seeking to market irradiated blood components in interstate commerce. The pilot program is intended to allow self- certification in lieu of the submission of a detailed biologics licence application (BLA) supplement. FDA is initiating the pilot program to determine if streamlining the process of licensing will be more efficient and effective for both the manufacturer and FDA without compromising product safety, purity, and potency.