Business Wire

LI-COR Submits Active Substance Master File for IRDye 800CW to European Regulatory Authorities and Registers Drug Master File with US FDA

LINCOLN, Neb.--(BUSINESS WIRE)--LI-COR Biosciences announces an Active Substance Master File (ASMF) for IRDye 800CW N-succidimidyl ester is on record with European regulatory authorities in support of ...
Royal Society of Chemistry

Using Regulatory Master Files for Investigational Products

A description of the various stages and sections of a Master Regulatory File (MRF) System. As an investigational product progresses through development key studies, decisions, regulatory ...
PharmiWeb

Proregulations Launches U.S. Drug Master File Document Production and Filing Service

With the evolution of pharmaceutical industry over the past decades, compliance remains a key factor in bringing novel drugs to market. Proregulations, as a product safety and regulatory consulting ...
MD&M East

Andersen Sterilizers Awarded First 510(k) Master File for EtO Sterility Change

In a major win for companies hoping to minimize the amount of ethylene oxide (EtO) needed to sterilize medical devices without the risk of 510(k) resubmission, Andersen Sterilizers and its contract ...
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FDA Releases Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements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 ...