Draft “Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components;” Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components" dated October 2002. The draft guidance document recognizes the "Circular of Information for the Use of Human Blood and Blood Components" (the circular) dated July 2002 as acceptable for use by manufacturers of blood and blood components intended for transfusion. The circular will assist those manufacturers in complying with the labeling requirements under FDA regulations.