FDA Workshop on Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design, and Endpoints

Mark your calendars for a workshop jointly sponsored by the Food and Drug Administration (FDA) and the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI). Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design and Endpoints Friday, October 27, 2017 The workshop will address challenges related to evaluation of products in pediatric heart failure including population to study, endpoints, and extrapolation of adult efficacy data. The workshop will also provide a forum for discussion on the use of registry data as well as alternative trial designs and statistical methods. Location/time: FDA's White Oak Campus, located at 10903 New Hampshire Avenue in Silver Spring, MD, from 8:00 a.m. to 5:00 p.m. Registration is required to attend. For the workshop agenda and registration information, please use the link below: https://oct27workshop.splashthat.com/ Best, Lily Mulugeta Yeruk.mulugeta_at_fda.hhs.gov<mailto:Yeruk.mulugeta_at_fda.hhs.gov>