Chronic Fatigue Meeting Shows Benefits, Hurdles To Patient-Focused Drug Development
The two-day workshop on chronic fatigue syndrome/myalgic encephalomyelitis elicited extensive, detailed testimony from patients about their symptoms and current treatment that will inform FDA policy, but it also underscored the challenges of explaining FDA’s regulatory processes to the patient community.
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Research centers are collaborating on projects to find causes of disease; Ampligen, Rituxan and KPAX-002 are only drugs in clinical trials.
The agency is seeking patient community input on process issues related to holding 20 meetings on disease-specific areas over the next five years under PDUFA V. FDA has proposed 39 medical conditions that could be considered for those disease-specific meetings.
Office of New Drugs Director Peter Stein tells the Pink Sheet that last phase of massive reorg was complicated by pandemic restrictions that forced review staff to work remotely, but the structural overhaul resulted in smaller, more nimble review groups and the breaking down of silos that ultimately helped the agency’s response to the public health crisis.