CROM Symposium, Online, 2020, CROM 02
The FDA Guidance on PROs and the Regulation of Modified Risk Tobacco Products (MRTP)
Department of Health Services, University of Washington, Seattle, WA, USA
The FDA PRO Guidance, over a decade in development and more than a decade after approval, set standards for incorporating the patient voice into medical product labeling. The regulatory context necessitates substantial evidence of effectiveness and...