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Dietary Supplements: FDA Issues Draft Guidance on NDIN Master Files

On April 3, 2024, FDA published Draft Guidance titled New Dietary Ingredient Notification Master Files for Dietary Supplements (the Draft Guidance). The Draft Guidance provides recommendations on how ...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

FDA Delays eCTD Requirements for Master Files

The US Food and Drug Administration (FDA) is giving drugmakers an additional year before requiring master files to be submitted in electronic common technical document (eCTD) format. In a revised ...
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 ...