Drug Repurposing: FDA IND Authority Lacks Levers To Better Direct Trial Resources In A Pandemic
Office of New Drug Director Peter Stein says there needs to be a better way to facilitate drug repurposing to avoid wasting time and resources on theories with little scientific probability of success.
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Research institutions, CROs, biopharma industry and other stakeholders are asked to comment on potential governance structure that would determine when trials are needed to address disease outbreaks and other public health emergencies.
Among hundreds of trials underway on potential therapeutics, only about 6% of study arms are expected to yield actionable data because most are nonrandomized, underpowered or underenrolled, Operation Warp Speed’s Janet Woodcock says, renewing her pitch for adoption of master protocols and other approaches to streamline studies and improve efficiency.
Legislation to delink PBM payments from drug prices advances in House Energy and Commerce health subcommittee, putting a key pharma priority closer to the finish line. Whether patients will see any benefit remains a worry.