2017 ACC/AAP/AHA Health Policy Statement on Opportunities and Challenges in Pediatric Drug Development: Learning from Sildenafil

Published: June 29, 2017

  • There are unique challenges in development and approval of medications for children, especially in children with rare diseases.
  • Two recent trials (STARTS-1 and STARTS-2) highlight many of the challenges in establishing safety, efficacy, and labeling facing pediatric drug design and approval.
  • The overarching goal of pediatric drug studies is to approve drugs that are safe and effective in children to improve care for pediatric populations.