Changes to an Approved Application: Biological Products. Human Blood and Blood Components Intended for Transfusion or for Further Manufacture. Guidance for Industry.

摘要

We, FDA, are providing you, manufacturers of licensed Whole Blood and blood components intended for transfusion or for further manufacture, including Source Plasma, with recommendations intended to assist you in determining which reporting mechanism is appropriate for submission of changes to an approved Biologics License Application (BLA) in accordance with the requirements under Title 21 of the Code of Federal Regulations (CFR) 601.12 (21 CFR 601.12), including recommendations in connection with the applicability and content of comparability protocols under 21 CFR 601.12(e) and labeling changes under 21 CFR 601.12(f).