FDA Casts Wide Net For Patient-Focused Meeting Topics
This article was originally published in The Pink Sheet Daily
Just a few slots remain under the agency’s original commitment under the PDUFA program, but the patient-engagement efforts appear highly valuable to FDA and industry alike.
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FDA report on CFS/myalgic encephalomyelitis is first of its kind from the patient-focused drug development initiative under PDUFA V. Incorporating comments from hundreds of patients and caregivers into a structured framework shows how the input may support a benefit/risk assessment for new products.
FDA is bringing an ongoing program to spur drug development for CFS and myalgic encephalomyelitis under the umbrella of the user fee program’s Patient-Focused Drug Development initiative, which calls for 20 patient-centric meetings over five years.
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.