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US FDA ‘Advancing Real-World Evidence Program’ Has First Entrants

 
• By Michael McCaughan

Agency is painting the new advice program as an attractive, ‘all-hands-on-deck’ option for sponsors beginning an RWE program for a new indication or a post-marketing commitment. With the first two slots filled, the next opportunity for sponsors has an end-of-September deadline.

all hands on deck
FDA thinks it can help get RWE applications rigged for success. • Source: Shutterstock

The US Food & Drug Administration is portraying its new “Advance Real-World Evidence” advice program as an attractive pathway for sponsors hoping to pursue new indications or to fulfill post-marketing commitments using non-traditional, “real world” data.

During a 6 June session of the annual FDA Regulatory Education for Industry (REdI) conference, the agency’s Kimberly Smith was asked what the advantages are for sponsors to participate in...

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