Systematizing Patient Views Unlikely, FDA’s Temple Says
Stakeholders want an objective way for patient views to be considered in a benefit-risk decision, but FDA’s Bob Temple says weighing patient decisions depends on imprecise things.
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FDA data requirements supporting novel drug approvals vary widely, depending on therapeutic area, with cancer drugs given greatest leniency, suggesting products may need a clinical trial “quality grade,” according to an analysis published in the Journal of the American Medical Association. Another study shows cancer treatments are most likely to get approved on the first try.
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.
Attorneys Sasinowski and Varond write that in some cases weak clinical evidence on the surrogate endpoint was not a barrier, but strong findings on unmet need and rarity usually are necessary for accelerated approval.