Regulatory Authority
‘Trying to take me out’: Tidmarsh’s exit at FDA pushes an agency in transition toward turmoil
FDA; George Tidmarsh; resignation; personal conduct probe; Kevin Tang; Center for Drug Evaluation and Research (CDER); agency turmoil; Vinay Prasad; leadership transitions; regulatory authority
FDA Threatens Action After Sarepta Refuses to Halt Elevidys Shipments
FDA; Sarepta Therapeutics; Elevidys; gene therapy; market withdrawal; patient deaths; Duchenne muscular dystrophy; liver failure; regulatory authority