Real-Time Oncology Review Has Sponsors Rethinking What Data To Share With US FDA And When
Pilot program that gives agency early look at pivotal data has forced sponsors to change how they go about preparing supplemental applications; potential expansion to new molecular entities would bring new challenges, including need to align manufacturing and clinical site inspections with expedited review timeline.
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Stephen Hahn also said the expedited approval process could be even more efficient.
Technology modernization efforts, the expansion of cloud-based submission capabilities, and the ongoing COVID-19 pandemic could serve as catalysts to broaden FDA’s Real-Time Oncology Review program beyond cancer therapeutics, Pfizer exec Richard Jahn says.
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.