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Food and Drug Administration (FDA) ME/CFS Resource Center

The Food and Drug Administration (FDA) approves drugs, medical devices, vaccines and regulates tobacco products, cosmetics, food products,etc., in the US.  It’s current budget is approximately 4 1/2 billion dollars a year.

Chronic fatigue syndrome may be the only major disorder in the United States without a single FDA approved drug.  An FDA official is a member of the federal advisory committee on CFS (CFSAC).

FDA Stakeholders Meeting

In 2011 a group of advocates began the groundwork to request that the FDA hold a ‘Stakeholder’s Meeting’ to accelerate the drug approval process for chronic fatigue syndrome (ME/CFS). Thanks to the work of hundreds of ME/CFS patient advocates, in July, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research, committed to holding a Stakeholders Meeting for ME/CFS in the fall of 2012.

Ampligen and the FDA

Ampligen has been the only drug under review at the FDA to treat chronic  fatigue syndrome for over 15  years.  It has been moved to five different sections in the FDA during that time.

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