After Pandemic, US FDA Commissioner Wants To Continue ‘Rolling Review’ Offered To COVID-19 Products
Stephen Hahn also said the expedited approval process could be even more efficient.
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One such trial is being developed, but was needed early in the pandemic to answer many lingering questions about potential COVID-19 treatments.
Pandemic Perspectives: NCATS Director Urges Rare Disease Community To Push Against Return To Clinical Trial Status Quo
Chris Austin argued the rare disease community deserves the same “movement of heaven and earth” mentality as was employed for COVID-19.
'Indirect and direct review roles' would be added with user fee funds after the PDUFA program is reauthorized.