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Tag Archives: Waive criteria for adequate and well-controlled studies
Dr. Woodcock: Please Approve Ampligen Now!
My letter to Dr. Woodcock from earlier this week: Jeannette K. Burmeister [email] [phone] [street] [street] [city, state, zip code] … Continue reading
Posted in Uncategorized
Tagged 21 CFR §312.80, 21 CFR §314.105(c), 21 CFR §314.126(c), accelrated approval, Ampligen, April FDA Drug Development Meeting, Bexsero, CFS, Chronic Fatigue Syndrome, Commissioner of the Food and Drug Administration, Dr. Margaret Hamburg, Dr. Theresa Michele, fast track, Improvements in exercise capacity, Improvements in immune-system markers, Jeannette Burmeister, Joseph Pitts, Letter to Dr. Woodcock, life threatening or severely debilitating disease, ME, ME/CFS, meningitis, meningococcus B, Myalgic Encephalomyelitis, Princeton University, priority review, Serious or life-threatening disease, surrogate end points, U.S. House of Representatives, UCSB, Unmet need, Vaccine, Waive criteria for adequate and well-controlled studies
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Thoughts About M.E. 