RAPS

FDA exploring model master files to expedite generic drug development

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, ...
JD Supra

Dietary Supplements: FDA Issues Draft Guidance on NDIN Master Files

On April 3, 2024, FDA published Draft Guidance titled New Dietary Ingredient Notification Master Files for Dietary Supplements (the Draft Guidance). The Draft Guidance provides recommendations on how ...
Yahoo Finance

GeminiBio Submits Drug Master File (DMF) to FDA

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 ...
JD Supra

New Draft FDA Guidance for Dietary Supplement Master Files

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 ...
Morningstar

NorthStar Secures FDA Acceptance of Drug Master File for No-Carrier-Added Actinium-225

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 ...
Morningstar

C-Ray Therapeutics Receives FDA Acceptance of Type II Drug Master File for Copper-64 (Cu-64)

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 ...
Pharmabiz

Stellar submits Biological Master File to US FDA for subunit KLH

Stellar Biotechnologies, Inc., the world leader in sustainable manufacture of Keyhole Limpet Hemocyanin (KLH), has submitted a Type IV Biologics Master File (BB-MF) to the US Food and Drug ...