News

BioPharma Dive11h
FDA plans to phase out animal testing for some drugs
The initiative, which will start with monoclonal antibodies, is the first big regulatory shift from the FDA since Martin ...
FDA plans to phase out animal testing in drugs in what it calls a ‘paradigm shift’
On Thursday, shares in Charles River Laboratories, a leading contract research organizations that has stirred controversy ...
National Law Review12h
District Court Strikes Down FDA’s LDT Rule, Opens the Door for Challenges to FDA’s Regulation of Other “Services” as Medical Devices
On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s ...
Fierce Pharma10h
After Hetlioz’s rejection in jet lag disorder, Vanda sues FDA for right to promote off-label use
After years of back-and-forth with the FDA over Hetlioz's potential use as a jet lag disorder treatment, Vanda ...