US FDA To Lose Another COVID-19 Response Leader With Anand Shah’s Resignation
Executive Summary
Shah, deputy commissioner for medical and scientific affairs, has been overseeing FDA’s COVID-19 Pandemic Recovery and Preparedness Plan. His departure the week of 20 January follows that of FDA Chief Counsel Amy Amin, whose resignation led to dueling appointments to temporarily fill her post.
You may also be interested in...
FDA’s COVID-19 Pandemic Plan Calls For Ongoing Clinical Trial Innovation
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.
FDA Chief Counsel Stacy Cline Amin Guided Agency Through COVID-19 EUAs And Guidances
Amin leaves after two-year stint, but Trump administration chaos continues as HHS names a different replacement chief counsel than FDA did earlier in the day. James Lawrence is tapped to be FDA's top lawyer and will presumably help speed a number of regulatory changes at the agency.
US FDA Faces Succession Questions As Hahn’s Departure Nears
Plan specifying the acting head of FDA until new commissioner is confirmed references senior positions that no longer exist.