FDA seeks advisory committee input on the benefits and risks of GRAIL's Galleri multi-cancer early detection test after two pivotal studies showed tha...
Three major pharmaceutical industry associations urge FDA to revise its proposed distributed manufacturing rule to provide greater flexibility for exi...
FDA has issued a direct final rule updating its regulations to clarify that non-animal testing methods may be used, where appropriate, to establish th...
A new Government Accountability Office finds gaps in FDA's oversight of third-party organizations that review 510(k) medical device submissions, inclu...
FDA classifies as Class 1 a CooperSurgical recall of certain INCA Infant Nasal CPAP Complete Sets and Neonatal Nasal CPAP Replacement Sets due to a lo...
FDA accepts for priority review an Insmed supplemental NDA seeking traditional approval for Arikayce (amikacin liposome inhalation suspension) for tre...
Ardelyx says it incorporated lessons from FDA's recent prescription drug advertising enforcement actions into its first television advertising campaig...
Staff from FDA and several drug companies use a Journal of Regulatory Affairs article to explain a 2024 FDA guidance on optimizing EDDO control strate...
