FDA-TRACK: Office of Combination Products (OCP) Performance Dashboards
First enacted in 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), the FDA User Fee Reauthorization Act of 2022, reauthorizes FDA to assess and collect fees for generic drug products from October 2023 through September 2027. GDUFA is designed to speed the delivery of safe and effective generic drugs to the public and improve upon the predictability of the review process.
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The Office of Combination Products (OCP) Performance Dashboards provide a concise, interactive, and visual presentation of data presented in the legislatively mandated OCP Performance Report to Congress (the Report) as required by the Medical Device User Fee and Modernization Act of 2002. The OCP Dashboards are not intended to replace the Report and are to be used as a supplemental tool for viewing the data. The OCP Dashboards reflect performance on submissions received and actions taken as of September 30, 2024. The OCP Dashboards present final performance in meeting the combination products review goals for FY 2023 and preliminary performance for FY 2024. Final OCP performance data for FY 2024 will be presented in the FY 2025 OCP Report and referenced in updated versions of the OCP Dashboards.
The FDA organizations providing information for the OCP Dashboards are the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH).
Prompt Assignment of Combination Products
Timely and Effective Premarket Review
Consistent and Appropriate Post Market Regulation
Effective Resolution of Review Disputes
Summary
OCP is responsible for resolving disputes regarding the timeliness of premarket review of combination products when formally requested by sponsors. Beyond formal dispute resolution, OCP facilitates communications between sponsors and FDA review staff to identify, clarify, and resolve specific concerns associated with review timeliness, helping to prevent the need for formal dispute resolutions. In FY 2024, OCP received no formal requests for dispute resolution for combination products, resulting in a zero percent dispute rate based on the total 645 combination product submissions received during the fiscal year. OCP also receives requests for dispute resolution and mediation on other regulatory issues beyond timeliness, such as inter-Center review disputes or requests by sponsors for assistance in understanding review decisions or resolving differences of view regarding regulatory requirements. OCP's proactive facilitation and informal resolution of issues, as demonstrated in the premarket review activities detailed earlier in this report, contribute to preventing formal disputes and ensuring efficient communication between sponsors and FDA review teams.