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Taking The ‘O’ Out Of RTOR: US FDA’s Real-Time Review Primed For Expansion Beyond Oncology

 
• By Sue Sutter

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.

road to horizon
US FDA could look to broaden the horizons of its Real-Time Oncology Review program. • Source: Shutterstock

The US Food and Drug’s Administration’s technology modernization program, the expansion of cloud-based submission capabilities, and the ongoing COVID-19 pandemic could serve as catalysts to broadly expand the agency’s Real-Time Oncology Review (RTOR) pilot.

The Oncology Center of Excellence’s well-regarded RTOR program is “highly likely” to expand in scope to other FDA review divisions and to other disciplines beyond clinical review, Richard Jahn, senior director of regulatory policy and intelligence at

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