Effective Resolution of Review Disputes OCP Requirements
Requirement: Report the Timeliness in Days of Dispute Resolutions Regarding Combination Products
FDA is to report the timeliness in days of dispute resolutions regarding combination products. No formal requests to resolve a dispute regarding the timeliness of a combination product review were received during FY 2008. This was the sixth straight year no formal requests were received. The “Activities and Impacts for FY 2008, Premarket Review” section of this report provides examples of informal facilitation and resolution of issues related to premarket review. Informal activities help prevent the need for formal dispute resolution.