FDA drafts patient-centric CFS guidance

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The experience of chronic fatigue syndrome may be a critical part of the FDA's approval process if new draft guidelines take hold. Regulatory Focus reports that the FDA is contemplating new rules, titled Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drugs for Treatment, that plays up the term “unmet medical need.”

RF says these three words could put potential treatments on the fast track. Yet the syndrome is a puzzler, in that tests can't detect the condition, which includes what the Centers for Disease Control and Prevention describes as overwhelming fatigue that can be accompanied by pain and impaired memory, among other symptoms.

RF notes that what makes the draft guidance significant is that the “FDA said it will be recommending some rather unique endpoints for CFS treatments,” including patient-reported symptoms and reliable outcome data.

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