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Dietary Supplements: FDA Issues Draft Guidance on NDIN Master Files

On April 3, 2024, FDA published Draft Guidance titled New Dietary Ingredient Notification Master Files for Dietary Supplements (the Draft Guidance). The Draft Guidance provides recommendations on how ...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

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) ...
PharmTech

Master File Submission of Structures

The SD File format offers benefits for KASA and cheminformatics to support regulatory submissions. Drug Master File (DMF) holders provide a hazard assessment for impurity classification to comply with ...