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Diane Murphy, MD, is the Director of the FDA's Office of Pediatric Therapeutics (OPT). The mission of OPT is to enforce a Congressional mandate that assures access for children to innovative, safe, and effective medical products.
Historically, many medical products have not been tested for use in children, leading to an increase in adverse events and the use of ineffective products.
Murphy notes that young children and neonates require the development of a new directional endpoint that can better help us to not treat children with our best guess, but with knowledge.