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Real-World Evidence User-Fee Funding Praised At FDA Meeting

Patient advocacy groups unanimously thanked FDA and industry for including patient engagement and real-world evidence elements in the new user-fee deal during a Nov. 2 meeting. RWE was initially a point of disagreement during negotiations between FDA and industry, but industry cautiously supported pilot funding.

The nascent National Evaluation System for health Technology was a consistent topic of debate between US FDA and industry during the past year's user-fee negotiations, but eventually made it into a tentative deal that will be presented to Congress for approval. At a Nov. 2 FDA public meeting on the user-fee deal, patient groups said they appreciated FDA and industry supporting the initiative, which initially got pushback from device-makers due to skepticism on how it would benefit companies in the pre-market setting.

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