FDA to partner with Brookings for PDUFA commitments

FDA plans to partner with the Engelberg Center for Health Care Reform (ECHCR), a think tank that is part of the Brookings Institution, to obtain input on the agency's implementation of its commitments under PDUFA V reauthorization. According to the funding opportunity announcement, FDA will provide $700,000 in FY13 to ECHCR, which will work to obtain stakeholder input on FDA's commitments, including developing patient-reported outcome measures to promote patient-focused drug development, facilitating rare disease drug development and developing a structured approach to FDA's benefit-risk assessments. Former FDA Commissioner Mark McClellan is director of ECHCR. ...