Completed BsUFA II Deliverables

Best Practices for Communication Between IND Sponsors and FDA During Drug Development Final Guidance  Updated guidance on best practices for communication between IND sponsors and FDA during drug development. Meeting Management Goals 12/29/2017 BsUFA II: Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act, Final Report Public Report Final assessment of the efficiency and effectiveness of the BsUFA review program, conducted by an independent contractor. Program for Enhanced Review Transparency and Communication for Original 351(k) BLAs 2/21/2022 BsUFA II: Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act, Interim Report Public Report Interim assessment of the efficiency and effectiveness of the BsUFA review program, conducted by an independent contractor. Program for Enhanced Review Transparency and Communication for Original 351(k) BLAs 12/2/2020 BsUFA Quarterly Hiring Updates Website Posting / Update Quarterly hiring data to provide updates on the status of BsUFA-hired FTEs. Set Clear Goals for Human Drug Review Program Hiring Last Updated: 4/12/2022 Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product Final Guidance  Publish final guidance on the clinical pharmacology data necessary to support a demonstration of biosimilarity. Advancing Development of Biosimilar Biological Products Through Further Clarification of the 351(k) Regulatory Pathway 12/29/2016 Considerations in Demonstrating Interchangeability With a Reference Product Final Guidance  Final guidance describing considerations for designating biosimilar biological products as interchangeable to a reference product. (Draft guidance published 1/18/2017) Advancing Development of Biosimilar Biological Products Through Further Clarification of the 351(k) Regulatory Pathway 5/10/2019 Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Draft Guidance Draft guidance describing the Agency’s recommendations on the design and evaluation of comparative analytical studies. Advancing Development of Biosimilar Biological Products Through Further Clarification of the 351(k) Regulatory Pathway 5/21/2019 FDA Final Hiring and Retention Assessment, Final Report Public Report Final study including the current state and recommended options for hiring processes and staff capacity. Comprehensive and Continuous Assessment of Hiring and Retention 12/10/2021 FDA Interim Hiring and Retention Assessment Report Public Report Interim study including the current state and recommended options for hiring processes and staff capacity. Comprehensive and Continuous Assessment of Hiring and Retention 6/5/2020 FDA PDUFA Hiring and Retention Final Assessment Public Meeting Public Meeting Public meeting to discuss the final assessment of FDA Hiring and Retention. Comprehensive and Continuous Assessment of Hiring and Retention 3/15/2022 FDA PDUFA Hiring and Retention Interim Assessment Public Meeting Public Meeting Public meeting to discuss the interim assessment of FDA Hiring and Retention. Comprehensive and Continuous Assessment of Hiring and Retention 7/30/2020 Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments (FY2019) Public Meeting Public meeting to invite comments on financial transparency and efficiency of the user fee acts. Enhancing Management of User Fee Resources 6/7/2019 Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments (FY2020) Public Meeting Public meeting to invite comments on financial transparency and efficiency of the user fee acts. Enhancing Management of User Fee Resources 6/22/2020 Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments (FY2021) Public Meeting Public meeting to invite comments on financial transparency and efficiency of the user fee acts. Enhancing Management of User Fee Resources 6/28/2021 Five-Year Financial Plan Fiscal Years 2018-2019-2020-2021-2022, 2018 Version, for BsUFA Public Report FDA’s initial five-year financial plan which will be updated annually. Financial Transparency and Efficiency 3/29/2018 Five-Year Financial Plan Fiscal Years 2018-2019-2020-2021-2022, 2019 Update, for BsUFA Public Report 2019 update to FDA’s five-year financial plan. Financial Transparency and Efficiency 5/31/2019 Five-Year Financial Plan Fiscal Years 2018-2019-2020-2021-2022, 2020 Update, for BsUFA Public Report 2020 update to FDA’s five-year financial plan. Financial Transparency and Efficiency 3/31/2020 Five-Year Financial Plan Fiscal Years 2018-2019-2020-2021-2022, 2021 Update, for BsUFA Public Report 2021 update to FDA’s five-year financial plan. Financial Transparency and Efficiency 3/30/2021 Five-Year Financial Plan Fiscal Years 2018-2019-2020-2021-2022, 2022 Update, For BsUFA Public Report 2022 update to FDA’s five-year financial plan. Financial Transparency and Efficiency 3/30/2022 Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Draft Guidance  Revised draft guidance on formal meetings between FDA and sponsors. Meeting Management Goals 6/5/2018 FY2018 Human Drug User Fees Financial Management Evaluation Public Report Evaluation of PDUFA, BSUFA, and GDUFA program resource management during FY 2018. Enhancing Management of User Fee Resources 5/22/2019 Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications Draft Guidance Revised draft guidance on good review management principles and practices. First Cycle Review Management 9/25/2018 Independent Evaluation of the PDUFA and BsUFA Resource Capacity Planning Adjustment Methodology Public Report Evaluation of options and recommendations for the new methodology to accurately assess changes in the resource and capacity needs of the human drug review program. Resource Capcaity Planning and Modernized Time Reporting 4/3/2020 Initial Assessment of FDA Hiring and Retention – A Path Forward Public Report Initial baseline study including the current state and recommended options for hiring processes and staff capacity. Comprehensive and Continuous Assessment of Hiring and Retention 11/15/2017 Initial Public Meeting on FDA Hiring and Retention – A Path Forward Public Meeting Public meeting to discuss the intial assessment of FDA Hiring and Retention. Comprehensive and Continuous Assessment of Hiring and Retention 11/30/2017 Labeling for Biosimilar Products Final Guidance  Publish final guidance on the labeling for biosimilar products. Advancing Development of Biosimilar Biological Products Through Further Clarification of the 351(k) Regulatory Pathway 7/19/2018 New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2) Draft Guidance Publish draft guidance on the processes and considerations related to post-approval manufacturing changes for biosimilar biological products.  Advancing Development of Biosimilar Biological Products Through Further Clarification of the 351(k) Regulatory Pathway 12/11/2018 Nonproprietary Naming of Biological Products Final Guidance  Publish final guidance on the nonproprietary naming of biological products. Advancing Development of Biosimilar Biological Products Through Further Clarification of the 351(k) Regulatory Pathway 1/13/2017 Public Meeting: Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act Public Meeting Final report on the assessment of the efficiency and effectiveness of the BsUFA review program, conducted by an independent contractor.  Program for Enhanced Review Transparency and Communication for Original 351(k) BLAs 3/22/2022 Public Meeting: Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act Public Meeting Interim report on the assessment of the efficiency and effectiveness of the BsUFA review program, conducted by an independent contractor.  Program for Enhanced Review Transparency and Communication for Original 351(k) BLAs 1/27/2021 Questions and Answers on Biosimilar Development and BPCI Act Guidance for Industry Final Guidance  Publish final guidance describing processes and further considerations related to post-approval manufacturing changes. Advancing Development of Biosimilar Biological Products Through Further Clarification of the 351(k) Regulatory Pathway 9/17/2021 Resource Capacity Planning & Modernized Time Reporting Implementation Plan Implementation Plan Implementation plan for FDA’s approach to resource capacity planning and modernized time reporting. Resource Capacity Planning and Modernized Time Reporting 3/30/2018 Statistical Approaches to Evaluate Analytical Similarity Draft Guidance Publish draft guidance on the evaluation of analytical similarity for biosimilar products.  Advancing Development of Biosimilar Biological Products Through Further Clarification of the 351(k) Regulatory Pathway Draft: 09/22/2017 Withdrawn: 6/21/2018

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