Representative Jake Auchincloss (D-MA) urges FDA whistleblowers to come forward to disclose instances of wrongdoing by agency managers.
FDA accepts a Telix Pharmaceuticals resubmitted NDA for TLX101-Px, an investigational PET imaging agent for glioma.
FDA cites significant manufacturing and quality control deficiencies at an active pharmaceutical ingredient facility operated by Orchid Pharma Limited...
FDA cautions BioCorRx about false and misleading information on the Web site home page for its Lucemyra.
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...
