Taking The ‘O’ Out Of RTOR: US FDA’s Real-Time Review Primed For Expansion Beyond Oncology
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.
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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.
The goal is a platform where sponsors could enter data that multiple regulators could view in real-time, rather than rely on ‘digital paper’ – pdfs and other static file formats that require health agencies to reenter the data in order to analyze it.
CDER wants sponsors to use the NextGen Portal for electronic submission of promotional pieces to the Office of Prescription Drug Promotion, rather than sending in paper or physical media such as CDs; availability of this alternative pathway does not affect requirement for eCTD submission of some types of promotional materials starting in June 2021.