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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Even if the agency had the legal power, it likely did not have the resources to oversee all clinical trials, rather than only those that qualified under the IND regulations, but the extra oversight could have increased coordination and ensured more data was fit for regulatory purposes.
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.