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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US FDA wants to use biosimilars for a demonstration of cloud-based technology, an idea mentioned to increase the use of real-time review and enhance data analysis.
The oncology branch of the US FDA’s biologics center does not believe RTOR would speed application reviews.
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.