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FDA Guidance for Industry: Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers



This guidance is intended to clarify Agency expectations regarding facility information that should be included in original new drug application(s) (NDA); abbreviated new drug application(s) (ANDA); original biologics license application(s) (BLA); amendments; supplements; chemistry, manufacturing, and controls (CMC) supplements; and resubmissions to these submission types.

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