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.
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finds gaps in FDA's oversight of third-party organizations that review 510(k) medical device submissions, including outdated audit policies and a lack of deadlines for completing audits and communicating deficiencies to participating organizations.
FDA cites Connecticut outsourcing facility Brookfield Medical/Surgical Supplies for inadequate investigations involving 13 out-of-specification potency results.
