(RTTNews) - Tasly announced that, in a landmark move for the cell therapy industry, the U.S. Food and Drug Administration has accepted a Device Master File (DMF) describing the first dedicated quality ...
On April 3, 2024, FDA published Draft Guidance titled New Dietary Ingredient Notification Master Files for Dietary Supplements (the Draft Guidance). The Draft Guidance provides recommendations on how ...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 ...
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 ...
In a major win for companies hoping to minimize the amount of ethylene oxide (EtO) needed to sterilize medical devices without the risk of 510(k) resubmission, Andersen Sterilizers and its contract ...
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 ...
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