FDA clears a Forest Devices 510(k) for the SignalNED Model RE System, a device that uses electroencephalogram technology to assess a patients neurolog...
Vanda criticizes FDA for failing to approve its NDA for tradipitant to treat gastroparesis.
Federal Register notice: FDA announces a 10/10 Vaccines and Related Biological Products Advisory Committee meeting to discuss and make recommendations...
Bionpharma recalls (Class 1) a single Batch (#2310083) of atovaquone oral suspension due to contamination with Cohnella bacteria.
Federal Register notice: FDA makes available a final guidance entitled Conducting Clinical Trials With Decentralized Elements that provides recommenda...
Braun Medical expands an earlier recall to add lnfusomat Space Infusion System/Large Volume Pump to previous recalled devices due to an erroneous alar...
FDA releases the forms FDA-483 with multiple observations from inspections at Granules India Limited and Gland Pharma, both drug manufacturers in Tela...
Joint comments from three major drug companies about pediatric inflammatory bowel disease drug development question why FDA does not allow broader use...
