US FDA’s COVID Master Protocol Guidance To Maintain Influence Post-Pandemic
Agency seeking comment on document intended to replace the just-issued guidance on COVID-19 treatment development as FDA stresses the value of master protocols for developing clinical knowledge.
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Califf Plans US FDA, NIH Collaboration On Postmarket Evidence Generation
NIH Director Nominee Monica Bertagnolli is on board with both agencies working to better determine how approved treatments work in the real-world, FDA Commissioner Robert Califf said.
‘Elites’ Need To Understand Clinical Development Remains Necessary For Drug Discovery, Woodcock Says
US FDA’s principal deputy commissioner continues to preach clinical trial reform, saying stakeholders must remember that understanding a molecule does not equate to understanding its impact on the body.
US FDA’s Woodcock Sees Clinical Trial Reform Coming, But ‘Not Wholly Optimistic’
Acting FDA commissioner says there are a lot of strong forces in the research and pharma industries that could curb efforts to make pandemic-related clinical trial reforms permanent.