FDA’s Bad Rap: Pazdur Steps Up as Agency Faces Leadership Turmoil and Regulatory Scrutiny

FDA; Richard Pazdur; Center for Drug Evaluation and Research (CDER); George Tidmarsh; regulatory reform; leadership instability; drug approval; Project Orbis; Oncology Center of Excellence (OCE); review delays

‘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

Sarepta Therapeutics Faces FDA Crackdown after Third Patient Death; George Tidmarsh Named Top FDA Drug Regulator; Multiple Drugs Rejected; Pharma Invests Billions in US Manufacturing

Sarepta Therapeutics; FDA; gene therapy; Elevidys; acute liver failure; clinical hold; George Tidmarsh; drug rejection; reshoring; pharmaceutical manufacturing