Business Wire

Trial Master File Reference Model Group Officially Affiliates with CDISC

AUSTIN, Texas--(BUSINESS WIRE)--CDISC today announced an expansion of its offerings with the official affiliation of volunteer-based Trial Master File (TMF) Reference Model Group. The combined ...
Morningstar

ARTMS Drug Master File for Gallium Production Technology Referenced with Telix’s Gozellix®

BURNABY, British Columbia, April 01, 2025 (GLOBE NEWSWIRE) -- Telix ARTMS, Inc. (ARTMS), a global leader in radioisotope production technologies, is pleased to announce that the drug master file ...
Business Insider

Bio-Techne Files Drug Master File With FDA For ExCellerate GMP IPSC Expansion Medium

(RTTNews) - Bio-Techne Corp. (TECH) announced Wednesday that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ExCellerate GMP iPSC Expansion Medium, ...
JD Supra

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 ...