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

The US FDA's forthcoming guidelines on how external groups can develop proposed draft guidance for agency consideration should discuss other ways for submitting patient experience data short of the formal guidance route, patient advocates said.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