Two Hyman, Phelps & McNamara attorneys describe the impacts on industry if FDA responds to a congressional push for more pre-review of direct-to-consu...
HHS secretary Robert F. Kennedy Jr. curtails his public commentary on vaccines as part of a deliberate political strategy by the Trump administration ...
The CDER Office of Prescription Drug Promotion says an Amneal patient brochure for its Avastin biosimilar Alymsys is false or misleading in several wa...
Minutes of the 3/10 and 3/12 PDUFA 8 reauthorization steering committee sessions, progress was reported on the America First fee incentive discussion,...
Granules India Ltd tightens oversight of its manufacturing operations at its largest facility based on FDA-documented compliance issues outlined in a ...
FDA cites GMP deficiencies at a facility operated by Thermo Fisher Scientific (Patheon Italia unit) in Ferentino, Italy.
FDA removes partial clinical hold against MacroGenics Phase 2 LINNET study evaluating the investigational cancer therapy lorigerlimab.
An FDA Matters column calls on FDA to fully enforce the laws against mass compounding of approved drugs that are not in shortage.
