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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Both sides want enhancements to deal with growth in cell and gene therapy, as well as work on regulatory decision tools and finance issues.
Commissioner Hahn says FDA will see data as it is compiled to speed review; enrollment criteria raises some eyebrows since Moderna plans to exclude patients with known history of SARS-CoV-2 infection from Phase III. The agency’s guidance on COVID-19 vaccine trials says that such exclusions are not necessary since screening is unlikely when a product would be delivered post-market.
FDA may be evaluating the future of accelerated approval, but data from the Pink Sheet’s Performance Tracker shows growth in the submissions and approvals over the past five years.