RWE Program Offers Sponsors Chance At Novel Uses, But In Exchange For Disclosing Proposals
The disclosure requirement to participate includes an option for the US FDA to include the ideas on new regulatory uses for real-world evidence in a guidance or speak about them at public forums in order to ‘promote innovation.’
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Collaboration Makes The (Real) World Go Round: Global Efforts Strive To Anchor RWE With Real-World Data Standards And Practices
Can the decentralized global healthcare ecosystem to turn real-world evidence from a buzzword to a useful approach to fit-for-purpose evidence generation?
US FDA’s Pazdur Suggests NCI Should Help Sponsors Enroll Clinical Trials For Innovative Drugs
Oncology sponsors would handle ex-US trial enrollment, but Pazdur feels tapping into the NCI network would improve trial speed and diversity. Biggest challenge will likely be generating sponsor enthusiasm for move that would involve giving up some control of development.
ODAC Applauds Effort, But Votes Against Y-mAbs’ I-Omburtamab In Neuroblastoma
US FDA advisory committee voted unanimously that there was not enough evidence to show the monoclonal antibody improves overall survival, but panelists are hopeful that real-world evidence could eventually get the orphan candidate over the finish line.