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RWE Program Offers Sponsors Chance At Novel Uses, But In Exchange For Disclosing Proposals

 
• By Derrick Gingery

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.’

Electronic health record
The Advancing Real-World Evidence Program will accept proposals twice per year. • Source: Shutterstock

US Food and Drug Administration officials are ready consider novel ideas for using real-world evidence to support labeling changes or meet postmarket requirements, but in return program participants must allow some public discussion of them.

Agency officials on 19 October announced the launch of the Advancing Real-World Evidence (RWE) Program, which is among the commitments...

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