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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How Should The US Government Coordinate Emergency Clinical Trials?
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.
COVID-19 Should Force ‘Soul Searching’ Over Fragmented US Clinical Trials System, Woodcock Says
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.
FDA’s Califf Defends CMS Drug Coverage Role, Blames Rx Industry Prices For US Health Woes
US FDA Commissioner defends role of his sister-agency CMS in determining drug coverage after his agency’s approvals. Califf weighs in on a variety of drug pricing topics – including the IRA, accelerated approval pricing, and obesity drug coverage – at the annual BIO meeting in Boston.