Office of Pediatric Therapeutics
MedSun: Newsletter #66, November 2011
The Office of Pediatric Therapeutics (OPT) is mandated by Congress. Its primary mission is to assure 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. Given its legislative mandate, OPT has developed four distinct yet interrelated programs to support FDA efforts to improve pediatric access.
Office of Pediatric Therapeutics. FDA Website. October 21, 2011.