FDA posts a draft guidance entitled Unique Device Identifier (UDI) Requirements for Combination Products.
Former CBER director Peter Marks says FDA should explain why it changed its Covid-19 vaccine policy in a way that did not promote transparency and gol...
FDA publishes a guidance with questions and answers on its various remote regulatory assessment tools.
FDA posts a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.
FDA grants regenerative medicine advanced therapy designation for enGene Holdings bladder cancer drug detalimogene.
Viatris plans to submit an NDA later this year for phentolamine ophthalmic solution 0.75% for treating presbyopia based on just-released data from a P...
FDA grants Syndax Pharmaceuticals a priority review of its supplemental NDA for Revuforj (revumenib) as a treatment for relapsed or refractory acute m...
Former GOP Rep. John Doolittle calls for immediate steps to reverse some of the FDA restructuring that he says will hurt regulated companies, patients...
