FDA Uses AdComm Process To Shine Light On Ampligen’s Troubled Development
Executive Summary
December’s Arthritis Advisory Committee review of Hemispherx’s drug provided FDA with the first public opportunity to explain in detail why the chronic fatigue syndrome drug, in development for almost 25 years, has not passed regulatory muster to date.
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Hemispherx 'Redoubling' US Efforts On Ampligen
Chronic fatigue drug received two FDA complete response letters, but company now agrees to additional study, new CEO says. Firm hopes Argentine approval also bodes well.
Chronic Fatigue Syndrome Presents Challenging Test Case For PDUFA V Program
The first of 20 patient-focused drug development meetings kicks off April 25 with a workshop on CFS and myalgic encephalomyelitis; FDA can expect to hear extensive patient testimony about an array of symptoms and co-morbid conditions, as well as some dissension within the patient community over how the two conditions should be viewed.
Chronic Fatigue Syndrome Will Be First Of PDUFA V’s Disease Area Meetings
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.