A CDER Manual of Policies and Procedures lists responsibilities for the Office of Surveillance and Epidemiology and other CDER offices dealing with th...
Tandem Diabetes Care updates its March recall of its Apple iOS t:connect mobile app in the U.S. due to an issue that can cause rapid depletion of a us...
Sen Susan Collins and a bipartisan group of her colleagues introduce the Creating Hope Reauthorization Act to extend until 2030 the FDA priority revie...
A University of Illinois Chicago College of Pharmacy petition calls on FDA to authorize a new form of monograph for biological products.
3D Communications shares the results from its survey of FDA advisory committee members on committee reform issues.
FDA clears a Surgical Planning Associates 510(k) for its new HipInsight 2.0 mixed-reality guidance system for hip arthroplasty.
FDA removes a partial clinical hold on Stoke Therapeutics zorevunersen (STK-001) and its use in children and adolescents with Dravet syndrome.
FDA gives BioVie the go-ahead to begin its Phase 2 SUNRISE-PD trial in Parkinsons disease patients.
