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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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.
The CDC panel’s mandate is to make recommendations for each specific vaccine brought forward, not ‘comparing two, three or four vaccines, and coming up with specific recommendations for each one independent of the other,’ chairman Jose Romero says as ACIP recommends use of Janssen’s COVID-19 vaccine under EUA.