Clinical Outcome Assessments To Be Developed Under US FDA Grants
The projects could help streamline rare disease drug development, along with the Rare Disease Cures Accelerator.
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US FDA proposed increasing staffing and resources for both programs during the next user fee program cycle, but industry representatives did not believe it necessary.
US FDA is looking for advice on how to design a clinical trial network to complete the third component of its Rare Disease Cures Accelerator Program, but it also wants advice on clinical trial networks more broadly. The rare disease network will need to be global given the more limited patient populations, the agency said.
Agency has issued two of four methodological draft guidances required under 21st Century Cures Act and convened workshops on the two documents still to come; industry, patient groups applaud FDA’s initiative but point to gaps in the guidance series, particularly around interactions with the agency on patient experience data and approaches to collecting patient preference information.