Vanda Pharmaceuticals says FDA should withdraw a legislative proposal in its budget package that the company says would lengthen NDA review times and ...
FDA and the device industry are nearing a final agreement on the next round of Medical Device User Fee Act (MDUFA VI) negotiations.
Medline Industries recalls (Class 1) its angiographic control syringes, warning the devices could cause severe injury or death.
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 ...
