Gottlieb Uses ASCO Platform To Unveil Two Pilot Programs To Speed Drug Review
US FDA commissioner outlines plans to allow partial submissions as soon as database locks and to create joint sponsor-agency review documents.
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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.
Real-Time Oncology Review Quickly Grows Popular; Venclexta Is Latest To Join Pilot
Genentech/AbbVie drug becomes the seventh product known to be pilot-testing US FDA's new pathway; our infographic details the program's goals and how it has been used so far for more efficient reviews of supplemental oncology indications.
US FDA’s Assessment Aid May Spell The End Of Dueling Advisory Committee Briefing Packages
Pilot project allows FDA conclusions about a drug’s efficacy and safety to be integrated with, but distinguished from, a sponsor’s own analysis; though currently used for reviews of oncology applications, template could become the basis for a consolidated advisory committee briefing document.