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...
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...
A new report by CDERs Office of Clinical Pharmacology says regulatory science will have to evolve alongside increasingly complex therapies, with great...
FDAs proposed drug user fee commitments could give drug and biologics sponsors several new opportunities to address manufacturing facility problems be...
FDA begins next month accepting requests from drug and biologics sponsors seeking to participate in the fifth and final year of its Chemistry, Manufac...
A bipartisan Senate bill intended to give patients and health care providers more information about where prescription drugs are manufactured loses tw...
