Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments

Mitchell Berger, submitting in a personal capacity, suggests that the FDA include a pediatric track, discuss the use of real-world data for post-market monitoring, and involve more diverse stakeholders like other government agencies and patient panels in the workshop. He argues that these additions would improve collaboration and address specific needs such as pediatric drug shortages and off-label use.