Drug development for M.E. and CFS | US Food and Drug Administration notice | 13 September 2012


For more details and to find the weblinks attached to this notice, click HERE


FDA will be planning a series of activities focused on drug development to treat the symptoms of Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME and CFS) in order to explore:

The burden of disease that impacts the quality of life for ME and CFS patients;
The quantitative outcome measures or endpoints that determine if disease symptoms improve with intervention; and
How drug efficacy should be clinically tested based on these endpoints or measurements.

Please send correspondence regarding ME and CFS to ME-CFS-Meeting@fda.hhs.gov.

Activities

Please Note: The list of activities will be updated as each activity is announced.

Teleconference between FDA and Patients/Patient Advocates – September 13, 2012

Background Information (PDF – 20KB)
Docket for questions/comments that are not addressed on the teleconference (Docket Number: FDA-2012-N-0962)
Response Letter to Questions and E-mails Regarding Teleconference Invitation (PDF – 22KB)
ME and CFS Stakeholder Teleconference Participant List (PDF – 43KB)
Transcript: September 13, 2012 (PDF – 239KB) Note: A transcript is not an official FDA document. Official documents will be posted to the Federal Register.

Additional Resources:

How FDA Evaluates Regulated Products: Drugs

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