FDA-TRACK: Office of the Chief Medical Officer - Office of Pediatric Therapeutics Dashboard
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The Office of Pediatric Therapeutics (OPT) has the primary mission 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 interrelated programs to support FDA efforts to improve information on pediatric therapeutics. Explore the progress OPT is making towards its performance goals below.
I. Improve public health by increasing transparency and educational outreach
Pediatric Medical Product Safety Measures
I. Provide a public assessment of post-marketing safety information for products studied in the pediatric population in an effort to enhance the understanding of safety issues that arise when products are used in a much broader manner in children than the limited exposures seen in pediatric trials
II. Neonatology, Ethics, and Guidance Activities
Pediatric Collaboration Measures
I. Enhance scientific content, ethical conduct and safety of pediatric trials in collaboration with international regulatory bodies
II. Enhance scientific content, ethical conduct and safety of international pediatric trials in collaboration with FDA colleagues
Download FDA-TRACK OCMO Office of Pediatric Therapeutics Dataset
Note: The data provided on this website are produced on an ongoing basis for performance management purposes and are subject to change due to updates of preliminary estimates, corrections, or other reasons.