Completed PDUFA VII Deliverables

Publish Draft, Revised, or Final Guidance on Digital Health Technologies Enhancing Use of Digital Health Technologies to Support Drug Development and Review 12/21/2021 Launch Rare Disease Endpoint Advancement Pilot Program Advancing Development of Drugs for Rare Diseases 9/30/2022 Develop STAR webpage Split Real Time Application Review (STAR) Pilot Program 10/1/2022 Publish FRN on Paired Meeting Program Enhancing Capacity to Review Complex Innovative Designs 10/20/2022 Publish FRN Announcing CMC Development and Readiness Pilot Facilitating Chemistry, Manufacturing, and Controls Readiness for Products with Accelerated Clinical Development 10/31/2022 Publish MAPP on Approaches to Meet CMC Challenges Facilitating Chemistry, Manufacturing, and Controls Readiness for Products with Accelerated Clinical Development 11/1/2022 Patient-Focused Drug Development Listening Meeting on Gene Therapy Products Patient-Focused Drug Development 11/15/2022 Publish FRN on Continuation of MIDD Advancing Model-Informed Drug Development 1/11/2023 Conduct DHT Public Meeting 1 Enhancing Use of Digital Health Technologies to Support Drug Development and Review 1/31/2023 Publish Website of DHT Committee Enhancing Use of Digital Health Technologies to Support Drug Development and Review 2/28/2023 Conduct Public Workshop on Negative Controls Optimization of the Sentinel Initiative 3/8/2023 Establish DHT Framework Document Enhancing Use of Digital Health Technologies to Support Drug Development and Review 3/23/2023 Publish Capacity Planning Implementation Plan Resource Capacity Planning Implementation 3/29/2023 Issue RFI for PFDD Enhancing the Incorporation of the Patient’s Voice in Drug Development and Decision-Making 5/2/2023 Conduct Innovative Manufacturing Public Workshop Advancing Utilization and Implementation of Innovative Manufacturing 6/8/2023 Conduct Public Meeting Financial Plan FY23 Financial Transparency 6/8/2023 Update Four-Part Harmony MAPP Enhancing Communication Between FDA and Sponsors During Application Review 8/25/2023 Conduct Public Workshop on Post Market Pregnancy Data Optimization of the Sentinel Initiative 9/18/2023 Develop and Update Data and Technology Modernization Strategy FY23 Develop Data and Technology Modernization Strategy 9/19/2023 Publish Draft, Revised, or Final Guidance on Drug Use Related Software Enhancing Use of Digital Health Technologies to Support Drug Development and Review 9/19/2023 Publish Revised Draft Guidance on Formal Meetings Between FDA and Sponsors Guidance, Clarity, and Transparency 9/22/2023 Publish Draft Guidance on Alternative Tools to Assess Manufacturing Facilities Alternative Tools to Assess Manufacturing Facilities Named in Pending Applications 9/22/2023 Issue Federal Register Notice Summarizing PFDD RFI Enhancing the Incorporation of the Patient’s Voice in Drug Development and Decision-Making 12/13/2023 Publish Public Report on Challenges and Barriers to Cloud Technologies Leverage Cloud Technology to Progress Regulatory Digital Transformation 12/27/2023 Conduct Public Workshop for CID Enhancing Capacity to Review Complex Innovative Designs 3/5/2024 Publish Capacity Planning Implementation Plan Updates FY24 Resource Capacity Planning Implementation 3/22/2024 Issue New Policies and Procedures for Reviewing Methodological Approaches and Study Protocols for REMS Modernization and Improvement of REMS Assessments 3/25/2024 Update Existing Policies and Procedures to Systematically Determine if Modifications to REMS are Needed Modernization and Improvement of REMS Assessments 3/25/2024 Update Relevant REMS Guidances to Incorporate REMS Assessment Planning into the Design of REMS Modernization and Improvement of REMS Assessments 5/6/2024 Conduct Public Meeting Financial Plan FY24 Financial Transparency 6/6/2024 Conduct DHT Public Meeting 2 Enhancing Use of Digital Health Technologies to Support Drug Development and Review 6/25/2024 Publish Combination Products Guidance Related to URRAs Advancing Development of Drug-Device and Biologic-Device Combination Products Regulated by CBER and CDER for Use-Related Risk Analysis (URRA) 7/8/2024 Publish Report on Public Workshop on Post Market Pregnancy Data Optimization of the Sentinel Initiative 7/11/2024 Publish Strategy Document on Innovative Manufacturing Technologies Advancing the Use and Implementation of Innovative Manufacturing Technologies 9/11/2024

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