Full Extent Of Clinical Trial Damage May Be Unknown Until Pandemic Ends, CBER’s Peter Marks Says
More patient-centric trial designs also may be coming due to pandemic-related advances, Marks says.
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Both federal agencies extended grants to help investigators adapt to the changes mandated by the COVID-19 pandemic.
Agency cites “unexpected and large drop in collections” in slashing user-fee-setting contract.
Broader use of adaptive trial designs and master protocols, checklist-based application review, and enhancement of real-world monitoring of products are among the recommendations of US FDA's COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) report, an effort months in making based on interviews with agency management, staff, and outside stakeholders.