RAPS

FDA issues guidances on facility readiness and early DMF assessments under GDUFA III

The US Food and Drug Administration’s (FDA) on 3 October released two draft guidances that implement new enhancements under the new Generic Drug User Fee Act (GDUFA III) program. One guidance covers ...
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 ...
The American Journal of Managed Care

FDA Approves New Maintenance Dosing for Lecanemab to Treat Early-Stage Alzheimer Disease

Lecanemab's maintenance dosing regimen is now approved for early-stage Alzheimer's, transitioning from biweekly to once every four weeks after 18 months. Phase 2 and 3 trials confirmed lecanemab's ...
Nasdaq

MediPharm Labs Enters United States Pharmaceutical Market with Submission of FDA DMF

DMFs are regulatory submissions filed with the FDA containing confidential, detailed information about manufacturing, processes, packaging, and stability of APIs to be used in medicinal products for ...
RAPS

FDA Proposes New Rule on Allowing the Use of DMFs for Transitioning Biologics

The US Food and Drug Administration (FDA) on Thursday proposed a new rule to allow certain biologics, originally approved under a new drug application (NDA), to continue relying on drug master files ...