What is the regulatory agency’s role in determining the length of the regulatory review period?

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Source: FAQ (MPEP-Based) BlueIron Update: 2024-09-30 10 Rules 5 Related FAQs This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice. The regulatory agency is responsible for determining the length of the regulatory review period for the approved product on which a patent term extension application is based. This determination is made based on the application and official regulatory agency records for the approved product. According to MPEP 2757 , “ Under 35 U.S.C. 156, the regulatory agency is responsible for the determination of the length of the regulatory review period for the approved product on which the application for patent term extension is based. ” This determination is crucial for calculating the potential patent term extension. Related Rules from the Manual of Patent Examining Procedure 10 rules Collapse Determination of Regulatory Review Period Based on Application and Official Records MPEP 2757 Regulatory Agency Determines PTE Review Period MPEP 2757 Regulatory Agency Determines PTE Review Period MPEP 2757 Regulatory Agency Determines PTE Review Period MPEP 2757 Regulatory Review Period Not Final Until Petitions and Hearings Resolved MPEP 2757 Regulatory Agency Determines PTE Review Period MPEP 2757 Regulatory Agency Determines PTE Review Period MPEP 2757 Deadline for Comments on Regulatory Review Information MPEP 2757 Patent Extension Requires Final Regulatory Review Determination MPEP 2757 Prohibited Separation of Regulatory Review into Testing and Approval Phases for Patent Extension Determination MPEP 2757 Permitted Other Related FAQs 5 FAQs Collapse How is the regulatory review period for an animal drug determined? What deadlines are set in the Federal Register Notice regarding regulatory review period determinations? When is a regulatory review period determination considered final? What information do...