Narcolepsy Meeting Focuses On Symptoms, But Some Urge Attention To Underlying Cause
In the fourth meeting conducted under FDA’s patient-focused drug development initiative, dozens of narcoleptics talked about the symptoms they would like new therapies to address. However, some patients said new drugs should go beyond providing mere symptom relief and target the root of the condition.
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FDA may conduct more than the 20 required meetings by the end of fiscal year 2017, but how will the patient-focused drug development program find its place in helping generate new drugs?
Fibromyalgia Patient Meeting Shines Light On Lesser Known Symptoms
While pain and fatigue are well-recognized symptoms of fibromyalgia, patients testifying at the PDUFA V disease area meeting gave FDA drug review staff insight into other health effects, such as visual disturbances.
Patient-Reported Outcomes Tools Should Be Symptom Specific, FDA Says
Agency favors symptom-focused assessments over global quality-of-life evaluations when considering whether the data can support a drug labeling claim for use in treating pediatric cancer. Measures used for EU reimbursement considerations are usually not sufficient for FDA labeling claims, official cautions.