FDA issues an alert about Bard Peripheral Vasculars Rotarex Atherectomy Systems due to risks of fracture or breakage.
A Pacific Research Institute white paper makes the case for a preemption defense in failure-to-market cases brought under state laws.
Cooley attorneys say a recent 4th Circuit Court of Appeals decision threatens the practice of medicine defense, giving FDA an additional enforcement m...
FDA grants Onc.AI a breakthrough device designation for its Serial CT Response Score AI model, which the company describes as an artificial intelligen...
FDA says the Medline Industries recall of integrated arterial catheters is Class 1.
Mainstream media reports based on anonymous sources say the White House is preparing an order to require HHS to fire a percentage of employees in FDA,...
A Buchanan Ingersoll petition asks FDA to maintain restrictions on cancer drug Tabloid ANDAs that are in the applicable product-specific guidance.
FDA grants Bracco Imaging a fast-track designation for its BR55 (perfluorobutane/nitrogen lipopeptide-coated microbubbles) injection for detecting are...
