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.
Law firm Sheppard breaks down some of FDAs proposals in its budget documents that industry should keep a close eye on, including new DTC ad authoritie...
FDA announces a 5/18 virtual public workshop aimed at advancing the use of novel surrogate endpoints in developing treatments for rare diseases.
