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, ...
The FDA has issued a discussion paper outlining potential approaches to regulating generative artificial intelligence (GenAI) ...
LAGUNA HILLS, Calif.--(BUSINESS WIRE)--PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell ...
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 ...
On April 3, 2024, FDA published Draft Guidance titled New Dietary Ingredient Notification Master Files for Dietary Supplements (the Draft Guidance). The Draft Guidance provides recommendations on how ...
Deerfield, Illinois, Feb. 27, 2025 (GLOBE NEWSWIRE) -- DEERFIELD, IL. February 27, 2025 – Vantage Specialty Chemicals, Inc., (Vantage) today announced that its VYCERIN™ API Glycerin, USP is listed on ...
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 ...
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 ...
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 ...
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 ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results