Representatives from FDA, the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency are working on alignment on clinic...
Indias The News Minute says FDA inspections at two Aurobindo drug manufacturing facilities raised concerns about equipment contamination.
FDA clears a Conformis 510(k) for its Conformis Hip System.
Charles Fisher, who founded an artificial intelligence company that works in drug clinical trials, urges FDA to develop a framework under which sponso...
CDRHer Michelle Tarver says FDA is participating in two collaborative communities and wants to be in 10 by the end of 2020.
FDA clears a UVision360 510(k) for the 3mm Luminelle Dx 360 Rotatable Disposable Sheath, an attachment for the Luminelle DTx Hysteroscopy System.
Public Citizen petitions FDA and the Drug Enforcement Administration to up-classify Tramadol and similar drugs from Schedule 4 to Schedule 2 under the...
CBER issues a SOPP on regulatory meetings under some user fee programs.