A PDUFA 8 negotiating subgroup reviews industrys counterproposal to FDAs facility lifecycle proposal.
Reuters reports exclusively that the telehealth firm Hims and Hers Health is selling GLP-1 pills for $100 less per month than the branded version offe...
Johnson & Johnson MedTech recalls multiple versions of its Cerepak Detachable Coil System, which are used to treat intracranial aneurysms and other ne...
FDA publishes a guidance with recommendations on computer software assurance for computers and automated data processing systems used as part of medic...
FDA updates the safety labeling for the widely used chemotherapy drugs capecitabine (Genentechs Xeloda) and fluorouracil (multiple manufacturers) to s...
President Trump signs a government spending bill that officially reinstates FDAs Rare Pediatric Disease Priority Review Voucher program.
FDA warns Austin, TX-based Flextronics America about Quality Systems violations in its manufacturing of a continuous glucose meter.
FDA warns Indias Cohance Lifesciences about CGMP violations in its production of drugs at one of its manufacturing sites.
