FDA seeks advisory committee input on the benefits and risks of GRAIL's Galleri multi-cancer early detection test after two pivotal studies showed that the blood-based screening test detected about one-third of cancers diagnosed within 12 months of testing.
FDA has issued a direct final rule updating its regulations to clarify that non-animal testing methods may be used, where appropriate, to establish the safety of drugs and biological products before human clinical trials.
FDA seeks advisory committee input on the benefits and risks of GRAIL's Galleri multi-cancer early detection test after two pivotal studies showed that the blood-based screening test detected about one-third of cancers diagnosed within 12 months of testing.
FDA has issued a direct final rule updating its regulations to clarify that non-animal testing methods may be used, where appropriate, to establish the safety of drugs and biological products before human clinical trials.
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 loose tubing connection.
A new Government Accountability Office finds gaps in FDA's oversight of third-party organizations that review 510(k) medical device submissions, including outdated audit policies and a lack of deadlines for completing audits and communicating deficiencies to participating organizations.
