BioCentury
ARTICLE | Regulation

PDUFA VII to be shaped by COVID-19 experience

Areas of consensus among FDA, stakeholders include funding the agency’s capacity to collect, analyze data

July 24, 2020 1:21 AM UTC

The COVID-19 experience, including the benefits of decentralized trials and virtual regulatory meetings, will shape negotiations over reauthorizing the Prescription Drug User Fee Act for fiscal years 2023-27.

Every PDUFA reauthorization has been accompanied by legislation that sought to reshape FDA. As Congress weighs in next year, it is certain to consider enhancing the agency’s ability to respond to infectious disease outbreaks and other emergencies. ...