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Guidance on Changes to Blood Product Application

11/21/2014

Federal Register Notice: FDA is making available a guidance document: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Guidance for Industry. It provides manufacturers of licensed whole blood and blood components intended for transfusion or for further manufacture, including source plasma, with recommendations concerning submission of changes to an approved BLA. It also provides manufacturers of licensed whole blood and blood components recommendations for the applicability and content of comparability protocols and labeling changes. The guidance applies to the manufacture and distribution of licensed products. It finalizes a 6/2013 draft guidance of the same title. To view this notice, click here.

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