Zdrowie i gospodarka · 3.01.2000
Draft ``Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture;'' Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture.'' The draft guidance document applies to the manufacture of all licensed Whole Blood, blood components, Source Plasma, and Source Leukocytes. The draft guidance document, when finalized, is intended to assist manufacturers in determining which reporting mechanism is appropriate for a change to an approved license application for Whole Blood, blood components, Source Plasma, and Source Leukocytes.