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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...

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