FDA Issues a Final Rule on Biologics License Applications, Investigational New Drug Applications and Master Files
JD Supra Law
FEBRUARY 21, 2024
On February 12, the FDA issued a final rule regarding the use of Drug Master Files (“DMF”) in Biologics License Applications. DMFs are submissions to the FDA “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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