When a generic drug application is reviewed and a regulatory decision is made, the sponsor may have concerns about the FDA's conclusions or may believe that not all information was considered. In such cases, sponsors can submit a Request for Reconsideration to the appropriate Division within the FDA.
Under the GDUFA, the FDA has outlined a specific process for handling Requests for Reconsideration at the Division level. This guidance is designed to ensure that manufacturers of generic drugs have a clear path to seek review of decisions made by the FDA regarding their submissions.