Seth Manilove

Seth Manilove

Goodwin

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FDA Issues a Final Rule on Biologics License Applications, Investigational New Drug Applications and Master Files

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...more

2/21/2024  /  Biologics , Death Master Files , Final Rules , Food and Drug Administration (FDA) , Incorporated by Reference , Investigational New Drug Application (IND) , Life Sciences , Pharmaceutical Industry
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