FDA Workshop on Drug Development in Pediatric Inflammatory Disease: Dose Selection, Exposure-response data, Extrapolation, and Innovative Trial Designs

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 Inflammatory Disease Friday, November 16, 2018 The workshop will discuss current barriers to expeditious pediatric IBD drug development and steps to overcome them. Specific topics will include a review of the legislation relevant to pediatric trials, extrapolation, trial design considerations, dose selection and the level of evidence required to establish safety and effectiveness Location/time: FDA's White Oak Campus, located at 10903 New Hampshire Avenue in Silver Spring, MD, from 8:30 a.m. to 5:00 p.m. Registration is required to attend. Remote participation provided. For the workshop agenda and registration information, please use the link below: Pediatric Inflammatory Bowel Disease (IBD) Workshop | Center of Excellence in Regulatory Science and https://cersi.umd.edu/pediatricIBD Best, Lily Mulugeta, Pharm.D Associate Director, Division of Pediatric and Maternal Health Office of New Drugs Center for Drug Evaluation and Research, FDA Yeruk.mulugeta_at_fda.hhs.gov<mailto:Yeruk.mulugeta_at_fda.hhs.gov>