The revised draft guidance from the US Food and Drug Administration (FDA) on drug master files (DMFs) deals with submissions on confidential information about facilities, manufacturing, processing, ...
WILMINGTON, Del.--(BUSINESS WIRE)--Noramco, LLC, a leading North American producer of controlled substance bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, today ...
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 ...
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 ...
OTTAWA, Ontario--(BUSINESS WIRE)-- BWXT Medical Ltd. has submitted a Drug Master File (DMF) to the U.S. Drug and Food Administration (FDA) for No Carrier Added (n.c.a.) Actinium-225 (Ac-225) Active ...
The US Food and Drug Administration (FDA) has released new draft guidance on how it assesses the completeness of drug master files submitted to it under generic drug applications, aiming to streamline ...
DMF No. 43568 is now active and available for reference in global IND and NDA submissions CHENGDU, China, April 28, 2026 /PRNewswire/ -- C-Ray Therapeutics (Chengdu) Co., Ltd., today announced that ...
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FDA has developed a new set of requirements for documenting the safety of dietary supplement ingredients. Manufacturers are able to market products with new ingredients without preapproval as long as ...
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