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 ...
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Dietary Supplements: FDA Issues Draft Guidance on NDIN Master Files

On April 3, 2024, FDA published Draft Guidance titled New Dietary Ingredient Notification Master Files for Dietary Supplements (the Draft Guidance). The Draft Guidance provides recommendations on how ...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

Akron Biotech Submits eCTD Drug Master Files with FDA for Its Suite of cGMP Immunotherapy Cytokines

BOCA RATON, Fla.--(BUSINESS WIRE)--Akron Biotechnology, which develops and manufactures cGMP-compliant cytokines and other ancillary materials to enable cell and gene therapy development and ...
MD&M East

Andersen Sterilizers Awarded First 510(k) Master File for EtO Sterility Change

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 ...