20 Is The Loneliest Number: FDA Disease Meeting Schedule Leaves Some Worried About Exclusion

Conflict among groups with conditions both included and not included in the preliminary list of public meeting topics prompts FDA to reiterate that the diseases will be selected because better clinical measures are needed, not because the agency will prioritize them over others.

FDA is working to allay advocates’ fears that the 20 disease areas to be selected for public meetings will be the agency’s sole focus during the PDUFA V program on patient input.

The meetings are part of the prescription drug user fee program’s increased efforts to gain patient opinions about pending treatments

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