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U.S. Department of Health and Human Services

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Assignment of Drugs Developed to Treat Chronic Fatigue Syndrome (CFS)

The Office of New Drugs (OND) recently announced a jurisdiction decision for products to treat chronic fatigue syndrome (CFS).

Applications for products being developed to treat chronic fatigue syndrome had previously been assigned to at least six different review divisions within OND. Across these applications, a variety of different endpoints have been evaluated in assessing products for CFS. More recently there has been interest in the development of endpoints such as instruments that rely upon patient reported outcomes. Developing such tools may help facilitate development of new products to treat patients with CFS and allow for a better means for assessment of the benefits such products provide to patients. 

The search for an underlying etiology or etiologies for CFS continues. Further research to understand the underlying etiology of CFS and the pathophysiology of the condition may also help in the development of new products. 

In order to work effectively with internal and external stakeholders on developing clinical trial endpoints (e.g., PRO instruments designed for assessing patient symptoms and response in CFS) and clinical trial designs, OND leadership have agreed to assign all CFS applications to a single OND review division, the Division of Pulmonary, Allergy, and Rheumatology Products (DPARP). This will allow for a coordinated and consistent process for review of products being developed for the treatment of CFS. In addition, consolidation to one division should allow for efficient and effective review, development of expertise within this area, and provide a single point of contact for CFS applications for stakeholders external to FDA. 

Effective immediately, all new applications for drug and therapeutic biologic products for CFS, regardless of the proposed mechanism for the therapeutic product or primary endpoint, will be assigned to DPARP. Existing active applications (NDAs and INDs) will be transferred to DPARP in an orderly manner (timing to be mutually agreed between the DPARP and the currently assigned division).