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There's More To Patient Experience Data Submissions Than Just Guidances, Advocates Tell US FDA

 
• By Sue Sutter

Forthcoming 'guidance on guidance,' required under 21st Century Cures Act, should explain different ways that advocacy groups can get patient experience data in front of FDA and provide an opportunity for early interactions before groups go down the guidance development route.

Guidance word in red keyboard buttons

The US FDA's forthcoming guidelines on how external groups can develop proposed draft guidance for agency consideration should discuss other ways for submitting patient experience data short of the formal guidance route, patient advocates said.

At a March 19 meeting convened by FDA, representatives from several advocacy organizations raised concerns that the agency's forthcoming draft...

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