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Steerage Issuing Business office

Heart for Biologics Evaluation and Research

Heart for Devices and Radiological Overall health

We (Food and drug administration or Agency) are offering guidance supposed to help applicants and producers of selected accredited biological products in identifying which reporting category is suitable for a change in chemistry, production, and controls (CMC) data to an approved biologics license application (BLA) as specified in Title 21 of the Code of Federal Regulations 601.12 (21 CFR 601.12) (i.e., write-up-approval changes) (Refs. 1 and 2).  The assistance describes standard and administrative information on assessing and reporting