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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Office of Clinical Policy and Programs

OCPP’s performance measures reported in the FDA-TRACK Program align to three categories: Combination Products, Orphan Product Development and Pediatric Therapeutics. Each activity is briefly described below with links to visualizations and dashboards. Explore the progress OCPP is making towards its performance goals on the FDA-TRACK website.

Office of Combination Products

Office of Combination Products (OCP) serves as a focal point for combination product (drug-device, biologic-device, drug-biologic, or drug-device-biologic products) issues for agency reviewers and industry.

Office of Orphan Products Development

Office of Orphan Products Development (OOPD) is dedicate to promoting the development of products (drugs, devices, biologics, and medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.

Office of Pediatric Therapeutics

Office of Pediatric Therapeutics (OPT) primary mission is to assure access for children to innovative, safe and effective medical products.


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