FDA Guidance for Industry: Drug Master Files

Titel:
FDA Guidance for Industry: Drug Master Files
Internet:
Herkunft/Verlag:

FDA

Inhalt:
This guidance provides FDA’s current thinking on drug master files (DMFs), which are submissions to FDA that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products

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