FDA Guidance for Industry: Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers
Titel:
FDA Guidance for Industry: Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER
Questions and Answers
Internet:
Herkunft/Verlag:
FDA
Inhalt:
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.