Latest From Brenda Sandburg
If Biden administration wants to nominate the acting commissioner, Vacancies Reform Act would dictate the timing. Woodcock can still get the nod and remain head of the agency during the confirmation process, just as Andrew von Eschenbach retained his acting title following his nomination in 2006.
President Biden’s picks to fill two commissioner posts may shift dynamics on pharmaceutical industry enforcement. Rohit Chopra’s nomination to Consumer Financial Protection Bureau removes strong critic of pharma mergers.
Our infographic illustrates the recommendations in FDA’s COVID-19 pandemic recovery and preparedness plan, ranging from strengthening the EUA process to managing the backlog of pending inspections.
Operation Warp Speed confirmed the necessity of having a facility on hand to develop and manufacture a vaccine for the next crisis, the outgoing advisor says.
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.
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.