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  1. FDA-TRACK: Agency-wide Program Performance



OPT’s 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 interrelated programs to support FDA efforts to improve information on pediatric therapeutics. Explore the progress OPT is making towards its performance goals below.

Outreach Measures

I. Improve public health by increasing transparency and educational outreach

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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. Pediatric Advisory Committee (PAC) Activities

III. Neonatology, Ethics, and Guidance Activities

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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

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Download OCPP OPT Dataset

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time.


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