Business Wire

Lantheus Holdings Announces Submission of Drug Master File for NM-01 in the U.S.

NORTH BILLERICA, Mass.--(BUSINESS WIRE)--Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global ...
Business Insider

Isotopia Molecular Imaging files Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for Lu n.c.a.

PETACH TIKVA, Israel, Aug. 18, 2020 /PRNewswire/ -- Isotopia Molecular Imaging is pleased to announce that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for no ...
Business Wire

ANP’s Polymeric Drug Excipient Drug Master File (DMF) Accepted and Published by the U.S. Food and Drug Administration (FDA)

NEWARK, Del.--(BUSINESS WIRE)--ANP Technologies, Inc. (ANP) announced that its drug master file (DMF) on its novel, nano-encapsulating polymer-based drug excipient, ANP001B has been accepted and ...
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

BWXT Medical Submits Drug Master File for Actinium-225 API to U.S. Food and Drug Administration

OTTAWA, Ontario--(BUSINESS WIRE)-- BWXT Medical Ltd. has submitted a Drug Master File (DMF) to the U.S. Drug and Food Administration (FDA) for No Carrier Added (n.c.a.) Actinium-225 (Ac-225) Active ...
Nasdaq

BIO-TECHNE ANNOUNCES SUBMISSION OF FDA DRUG MASTER FILE FOR EXCELLERATE GMP IPSC EXPANSION MEDIUM SUPPORTING STEM CELL THERAPY

MINNEAPOLIS, Dec. 20, 2023 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ...
JD Supra

Another step forward in digital health: FDA issues draft guidance for drug master files (DMFs) for electronics and software components of combination products regulated ...

On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ...
JD Supra

FDA Issues a Final Rule on Biologics License Applications, Investigational New Drug Applications and Master Files

On February 12, the FDA issued a final rule regarding the use of Drug Master Files (“DMF”) in Biologics License Applications. DMFs are submissions to the FDA “used to provide confidential, detailed ...
RAPS

Combo products, drug industry groups seek more clarity about cross-center master file guidance

Groups representing drugmakers and combination product manufacturers have asked the US Food and Drug Administration (FDA) for more clarity on its recently published draft guidance on the use of ...
The National Law Review

FDA Extends Deadline Requiring Drug Master Files in Electronic Format

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 ...
Yahoo Finance

NorthStar Secures FDA Acceptance of Drug Master File for No-Carrier-Added Actinium-225

FDA acceptance enables pharmaceutical development partners to directly reference NorthStar no-carrier-added (n.c.a.) Ac-225 DMF in IND and NDA submissions NorthStar’s regulatory and cGMP manufacturing ...
Business Insider

Bio-Techne Files Drug Master File With FDA For ExCellerate GMP IPSC Expansion Medium

(RTTNews) - Bio-Techne Corp. (TECH) announced Wednesday that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ExCellerate GMP iPSC Expansion Medium, ...