COVID Therapeutics Progress (Or Lack Thereof) May Be Political Vulnerability For US FDA
COVID treatments have not advanced as rapidly or as publicly as vaccines. That may trigger some issues for the US FDA as Congress digs into the next phase of the COVID response – and starts to assess agency performance and leadership after the crisis.
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US FDA COVID Funds Move Forward In Congress, No Strings Attached
Amendment to require one-firth of the money be devoted to therapeutic review was defeated by the House Energy and Commerce Committee.
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.
Exondys Approval: FDA Commissioner's Draft Decision Drew Internal Rebuke
Even at the final step, FDA’s review of Sarepta's Duchenne muscular dystrophy drug remained collaborative and contentious, as Commissioner Califf's view that accelerated approval would not set a new precedent drew pushback from ODE I Director Unger, while Acting Chief Scientist Borio said the draft decision downplayed the 'miniscule' amount of dystrophin with eteplirsen.