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“Patient Voice” Report Puts Chronic Fatigue Symptoms, Treatments In Benefit/Risk Framework

 
• By Sue Sutter

FDA report on CFS/myalgic encephalomyelitis is first of its kind from the patient-focused drug development initiative under PDUFA V. Incorporating comments from hundreds of patients and caregivers into a structured framework shows how the input may support a benefit/risk assessment for new products.

FDA’s first-ever report produced under its patient-focused drug development initiative incorporates the symptoms of, and treatments used for, chronic fatigue syndrome and myalgic encephalomyelitis (CFS/ME) into a modified version of the agency’s new benefit/risk assessment framework.

"The Voice of the Patient" report on CFS/ME contains a thorough recounting of patient and caregiver testimony on symptoms, disease burden and treatment options from an April 25-26 public meeting and in comments to the public docket

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