Biodiversity Protocol Requires Countries To Track Patents On Genetic Resources
Biopharma companies could see fewer investment and policy uncertainties for projects involving use of genetic resources under a new international framework that has been in the making for six years.
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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.