New COA Grant Funding Opportunity

FDA issued 7/9 a second Funding Opportunity Announcement (FOA) as part of the agency’s Standard Core COAs and Endpoints Pilot Grant Program. CDER director of patient-focused drug development and program offer for the FDA Standard Core Clinical Outcome Assessments (COAs) and Endpoint Pilot Grant Program Robyn Bent says the purpose of the second FOA is to solicit applications to support the development of a publicly available core set(s) of clinical outcome assessments and related endpoints for these four areas: fluid overload in nephrotic syndrome, age-appropriate domains of pediatric daily functioning, the mechanics of swallowing and speech from infancy to adulthood, and treatment effects in systemic sclerosis.

Bent notes that as part of the first funding opportunity last year, FDA began funding the development of standard core sets of COAs for pain in infants and young children, migraine, and physical function.