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Tag Archives: Bexsero
Ampligen: The FDA’s Unequal Treatment of a Second-Class-Citizen Drug
On December 11, 2013, I wrote a letter to the FDA’s Director of the Center for Drug Evaluation and Research, Dr. Janet Woodcock. I pleaded with her to use her considerable discretion and potentially accelerated procedures regarding the approval of … Continue reading
Posted in Uncategorized
Tagged Aricept, Belviq, Bexsero, Bob Miller, Canagliflozin, CFS, Chronic Fatigue Syndrome, Dr. Janet Woodcock, FDA, Invokana, ME, ME/CFS, Mindy Kitei, Myalgic Encephalomyelitis, Qsymia, Sirturo, Unequal Treatment
8 Comments
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
12 Comments
Thoughts About M.E. 