The US Food and Drug Administration (FDA) is giving drugmakers an additional year before requiring master files to be submitted in electronic common technical document (eCTD) format. In a revised ...
The US Food and Drug Administration (FDA) is exploring the use of model master files (MMFs) to enable sponsors to use the same modeling approach to support different generic drug development programs, ...
MINNEAPOLIS, Dec. 20, 2023 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ...
On April 3, 2024, FDA published Draft Guidance titled New Dietary Ingredient Notification Master Files for Dietary Supplements (the Draft Guidance). The Draft Guidance provides recommendations on how ...
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 ...
FDA acceptance enables pharmaceutical development partners to directly reference NorthStar no-carrier-added (n.c.a.) Ac-225 DMF in IND and NDA submissions NorthStar’s regulatory and cGMP manufacturing ...
WEST SACRAMENTO, Calif., March 13, 2025 /PRNewswire/ — Gemini Bioproducts, LLC (“GeminiBio”), a biopharma and advanced therapy raw materials supplier, and a portfolio company of BelHealth Investment ...
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