Pulmonary Fibrosis Patients Talk Quality Of Life More Than Potential New Treatments
FDA patient-focused drug development meeting on IPF mostly addresses ways to cope with symptoms.
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InterMune’s pirfenidone and Boehringer Ingelheim’s nintedanib are neck-and-neck in the race to be the first drug interventions in the U.S. for the fatal lung disease. Phase III data from both drugs were presented at the American Thoracic Society meeting and published in the NEJM May 18.
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.
Rare Disease groups work to finalize white paper on accelerated approval, but FDA questions whether a rules-based biomarker qualification process is possible.