DeGette’s Office Signals FDA Is Comfortable With Revised ‘Cures’ Clinical Trials Language

Rep. Diana DeGette (D-CO) believes the updated 21st Century Cures draft bill gives FDA adequate flexibility when it comes to streamlining clinical research -- such as biomarker development and adaptive trial designs -- by directing the agency to issue guidance rather than mandating it adopt a specific practice, a congressional aide told Inside Health Policy Friday (May 1). Agency officials had earlier warned lawmakers against pursuing clinical trial reforms that could weaken current drug safety and efficacy standards, but FDA...