"Guidance for Industry: Recognition and Use of a Standard for the Uniform Labeling of Blood and Blood Components;" Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled "Guidance for Industry: Recognition and Use of a Standard for the Uniform Labeling of Blood and Blood Components." The guidance document describes a system for the uniform labeling of blood and blood components for transfusion, Source Plasma, and other components for use in further manufacturing. The guidance will assist manufacturers in complying with the labeling requirements under FDA's regulations.