Nasdaq

FDA Accepts Tasly's Device Master File, Setting First Quality Control Standard For MSCs

(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 ...
La Grande Observer

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 ...
RAPS

FDA guidance outlines where to send “cross-center” master files

The US Food and Drug Administration (FDA) has issued a draft guidance to industry that specifies where sponsors should submit “cross-center” master files (MFs) that are referenced and intended to ...
ksn.com

Cellbox Solutions Submits Device Master File (DMF) to the U.S. FDA

Submission represents an important step towards establishing the Cellbox Live Shipment Technology as a new standard for warm chain logistic in the cell therapy sector Cellbox customers can now ...
RAPS

FDA Drafts Guidance on Type V DMFs for Combination Products

The US Food and Drug Administration (FDA) on Monday issued draft guidance detailing when a Type V drug master file (DMF) can be used to provide information about Center for Drug Evaluation and ...
Business Wire

Andersen Sterilizers & Andersen Scientific First Awardee in FDA’s 510(k) Ethylene Oxide Sterility Change Master File Pilot Program

HAW RIVER, N.C.--(BUSINESS WIRE)--Andersen Sterilizers and its sister company, contract sterilization specialist Andersen Scientific, were awarded the very first master file in the FDA's 510(k) ...