Patent Reviews Gave Innovators Headaches In 2015; Will Relief Come This Year?
Inter partes review process picked up steam as generic manufacturers, biosimilar sponsors, and hedge fund manager Kyle Bass filed slew of petitions challenging validity of drug patents.
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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.