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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A proposed pilot program would offer for “split submission and review” of some application sections in other disease areas. Discussions also touch on concept of a CDER-CBER RWE committee.
Agency staff, stakeholders see advantages to bundling requirements for fast-track and RMAT designations into a single, pre-breakthrough therapy pathway, and codifying processes and interactions that take place following award of breakthrough designation; proposal is aimed at reducing current programs' redundancies and maximizing benefit of frequent, early interactions with the FDA.
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.