FDA Seeks Public Input on Use of Type V Drug Master File for Generic Drug Approvals
January 18, 2025
January 18, 2025
WASHINGTON, Jan. 18 (TNSFR) -- The Food and Drug Administration (FDA) has announced the establishment of a public docket to solicit comments on the use of a Type V Drug Master File (DMF) for Model Master File (MMF) submissions. This initiative aims to gather input on how these submissions could support Abbreviated New Drug Applications (ANDAs), enhancing the development and approval of generic drugs.
The FDA is particularly interested in feedback on the use of in silico models, suc . . .
The FDA is particularly interested in feedback on the use of in silico models, suc . . .