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 document entitled "Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components" dated December 2003. The 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 manufacturers in complying with the labeling requirements under FDA regulations. The guidance announced in this notice finalizes the draft guidance of the same title dated October 2002.