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Dietary Supplements: FDA Issues Draft Guidance on NDIN Master Files

On April 3, 2024, FDA published Draft Guidance titled New Dietary Ingredient Notification Master Files for Dietary Supplements (the Draft Guidance). The Draft Guidance provides recommendations on how ...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

FDA Releases Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
JD Supra

New Draft FDA Guidance for Dietary Supplement Master Files

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 ...
Business Wire

ChemWerth Files its 500th Drug Master File with FDA

WOODBRIDGE, Conn.--(BUSINESS WIRE)--ChemWerth Inc., a leading supplier of generic Active Pharmaceutical Ingredients (APIs), filed a Drug Master File (DMF) with the Food and Drug Administration (FDA) ...
BioWorld

FDA introduces another sterilization master file pilot program

Seemingly in response to the release of a proposed rule for ethylene oxide emissions by the U.S. Environmental Protection Agency, the U.S. FDA has released a second pilot program for device master ...
Yahoo Finance

Akadeum Life Sciences Announces Drug Master File Submission to the US FDA for GMP Microbubble Cell Separation

ANN ARBOR, Mich., Nov. 18, 2025 /PRNewswire/ -- Akadeum Life Sciences, the leader in buoyant cell separation, announced today that it has submitted a Type II Drug Master File (DMF) to the U.S. Food ...