Completed PDUFA VI Deliverables
Since the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, user fees have played an important role in expediting the drug approval process. PDUFA must be reauthorized every five years, and in August 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA), that includes the reauthorization of PDUFA through fiscal year 2022. To provide a snapshot of how FDA is meeting its commitments, the following table provides a listing of completed deliverables required under PDUFA. This table represents the original deliverables that FDA produced to meet its commitments, but it does not necessarily include more recent versions that may have posted after the deliverables were met.
Please note the summary table does not include deliverables intended for internal use, including:
- Updates to internal policies and procedures,
- Program updates or pilot programs,
- Staff training requirements and
- Interim milestones (e.g., Federal Register notices).
For more detailed information regarding PDUFA performance progress, please see the PDUFA Annual Performance Report page.
| Deliverable Title | Type | Description | Reference | Date Published |
|---|---|---|---|---|
| Assessment in Support of Sentinel System | Public Report | FDA’s assessment of the Sentinel system including the analysis and reporting of the impact of the Sentinel expansion and integration on FDA’s use of Sentinel for regulatory purposes. | Enhancement and modernization of the FDA Drug Safety System | 9/30/2022 |
| 2018 Public Meeting on Electronic Submissions and Data Standards | Public Meeting | Annual meeting to solicit stakeholder input regarding the electronic submission system. | Enhance Transparency and Accountability of FDA Electronic Submission and Data Standards Activities | 7/10/2018 |
| 2019 Public Meeting on Electronic Submissions and Data Standards | Public Meeting | Annual meeting to solicit stakeholder input regarding the electronic submission system. | Enhance Transparency and Accountability of FDA Electronic Submission and Data Standards Activities | 4/10/2019 |
| 2020 Public Meeting on Electronic Submissions and Data Standards | Public Meeting | Annual meeting to solicit stakeholder input regarding the electronic submission system. (Meeting cancelled) | Enhance Transparency and Accountability of FDA Electronic Submission and Data Standards Activities | |
| 2021 Public Meeting on Electronic Submissions and Data Standards | Public Meeting | Annual meeting to solicit stakeholder input regarding the electronic submission system. | Enhance Transparency and Accountability of FDA Electronic Submission and Data Standards Activities | 4/7/2021 |
| 2022 Public Meeting on Electronic Submissions and Data Standards | Public Meeting | Annual meeting to solicit stakeholder input regarding the electronic submission system. | Enhance Transparency and Accountability of FDA Electronic Submission and Data Standards Activities | 4/12/2022 |
| Adaptive Design for Clinical Trials of Drugs and Biologics | Final Guidance | Final guidance on complex adaptive trial designs. (Draft guidance published 9/28/2018) | Enhancing Regulatory Decision Tools to Support Drug Development and Review | 11/29/2019 |
| Advancing the Development and Implementation of Analysis Data Standards: Key Challenges and Opportunities | Public Meeting | Public meeting to bring the stakeholder community together to discuss challenges and opportunities to advance analysis data standards. | Enhancing Regulatory Decision Tools to Support Drug Development and Review | 6/12/2019 |
| Analyze and Report on the Impact of Sentinel | Website Posting / Update | Summary of how select analyses conducted in Sentinel's ARIA system have been used by FDA. | Enhancement and Modernization of the FDA Drug Safety System | |
| Assessment of Combination Product Review Practices in PDUFA VI | Public Report | Independent third-party assessment to identify best practices and areas for improvement by FDA review staff and sponsors in the submission and review of combination products for consideration by both FDA and sponsors. | Enhancing Regulatory Science and Expediting Drug Development | 8/28/2020 |
| Assessment of FDA-Sponsor Communication Practices During the IND Stage of Drug/Biologic Development | Independent third-party assessment of IND FDA-sponsor communication practices in PDUFA VI. | Enhancing Regulatory Science and Expediting Drug Development | 6/17/2020 | |
| Assessment of Systems and Processes to Support Evaluation of Postmarket Safety Signals | Public Report | Independent third-party assessment of FDA processes and systems to support evaluation of postmarket safety signals | Enhancement and Modernization of the FDA Drug Safety System | 2/7/2023 |
| Benefit-Risk Assessment for New Drug and Biological Products | Draft Guidance | Draft guidance on benefit-risk assessments for new drugs and biologics. | Enhancing Regulatory Decision Tools to Support Drug Development and Review | 9/29/2021 |
| Benefit-Risk Assessment in Drug Regulatory Decision-Making (Draft PDUFA VI Implementation Plan (FY 2018-2022)) | Implementation Plan | Updated implementation plan regarding the agency's continued implementation of structured benefit-risk assessment in the human drug review program. | Enhancing Regulatory Decision Tools to Support Drug Development and Review | 3/30/2018 |
| BEST (Biomarkers, EndpointS, and other Tools) Resource | Draft Guidance | Developed in partnership with NIH, a glossary and taxonomy for biomarkers, endpoints, and other drug development tools. | Enhancing Regulatory Decision Tools to Support Drug Development and Review | Last Updated: 5/2/2018 |
| Best Practices for Development and Application of Disease Progression Models | Public Workshop | Workshop on model informed drug development and best practices for disease progression model development, including natural history and trial simulation. | Enhancing Regulatory Decision Tools to Support Drug Development and Review | 11/19/2021 |
| BQ submissions | Website Posting / Update | List of current BQ submissions. | Enhancing Regulatory Decision Tools to Support Drug Development and Review | Last Updated: 9/23/2021 |
| Bridging for Drug-Devise and Biologic Device Combination Products: Draft Guidance for Industry | Draft Guidance | Draft guidance to provide recommendations to industry and FDA staff on how to approach bridging in new drug applications or biologics license applications. | Enhancing Regulatory Science and Expediting Drug Development | 12/18/2019 |
| CBER-CDER Data Standards Program Action Plan | Public Report | Quarterly update to the data standards action plan. | Enhance Transparency and Accountability of FDA Electronic Submission and Data Standards Activities | Last updated: 5/6/2022 |
| Characterizing FDA's Approach to Benefit-Risk Assessment throughout the Medical Product Life Cycle | Public Meeting | Public meeting to discuss the implementation and communication of FDA's benefit-risk assessment framework. | Enhancing Regulatory Decision Tools to Support Drug Development and Review | 5/16/2019 |
| Combination Product Contacts | Website Posting / Update | Posting of key points of contact for combination product review in the Office of Combination Products and medical product centers. | Enhancing Regulatory Science and Expediting Drug Development | Last updated: 12/1/2021 |
| Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications | Draft Guidance | Draft guidance describing submission procedures for Human Factors protocols for NDAs and BLAs. | Enhancing Regulatory Science and Expediting Drug Development | 9/28/2018 |
| Development of Best Practices in Physiologically Based Pharmacokinetic Modeling to Support Clinical Pharmacology Regulatory Decision-Making | Public Workshop | Workshop on model informed drug development approaches using physiologically based pharmacokinetic analyses as part of the model informed drug development workshop series. | Enhancing Regulatory Decision Tools to Support Drug Development and Review | 11/18/2019 |
| Drug Development Tool Process Under the 21st Century Cures Act and PDUFA VI | Public Meeting | Public meeting to discuss the Drug Development Tool Qualification at FDA. | Enhancing Regulatory Decision Tools to Support Drug Development and Review | 12/11/2018 |
| Electronic Submission and System Status | Website Posting / Update | Web resource that includes published targets for and measures ESG availability along with current ESG operational status updates and published submission isntructions in the event of a service disruption. | Improve the Predictability and Consistency of PDUFA Electronic Submission Process | Last updated: 2/9/2022 |
| Eleventh Annual Sentinel Initiative Public Workshop | Public Meeting | Gathering of the Sentinel community and leading experts to promote collaboration. | Enhancement and Modernization of the FDA Drug Safety System | 4/3/2019 - 4/4/2019 |
| Enhancing the Incorporation of Patient Perspectives on Clinical Trials | Public Meeting | Public meeting to discuss patient participation in clinical trials and incorporation of patient perspectives into clinical trials design. | Enhancing Regulatory Decision Tools to Support Drug Development and Review | 3/18/2019 |
| Enhancing the Incorporation of Patient Perspectives on Clinical Trials Meeting Summary | Public Report | Meeting summary of public meeting to discuss patient participation in clinical trials and incorporation of patient perspectives into clinical trials design. | Enhancing Regulatory Decision Tools to Support Drug Development and Review | |
| ESG and Standard Metrics - Submission Statistics | Website Posting / Update | Postings of historic and current metrics on Electronic Submission Gateway (ESG) performance. | Enhance Transparency and Accountability of FDA Electronic Submission and Data Standards Activities | Last updated: 6/10/2022 |
| FDA Data Standards Catalog | Website Posting / Update | Up-to-date and current catalog for agency data standards. | Enhance Transparency and Accountability of FDA Electronic Submission and Data Standards Activities | Last updated: 3/22/2022 |
| 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 |
| FDA-ISoP Public Workshop: Model Informed Drug Development (MIDD) for Oncology Products | Public Workshop | Jointly held workshop on model informed drug development for oncology products. | Enhancing Regulatory Decision Tools to Support Drug Development and Review | 2/1/2018 |
| 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 PDUFA | 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 PDUFA | 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 PDUFA | 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 PDUFA | 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 PDUFA | 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 PDUFA Products | Draft Guidance | Revised draft guidance on formal meetings between FDA and sponsors. | Meeting Management Goals | 12/28/2017 |
| 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 | Updated GRMP guidance to include review activities that have been added to the human drug review program. | 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 |
| Independent Third-Party Assessment of IND FDA-Sponsor Communication Practices in PDUFA VI | Public Meeting | Public meeting to present and discuss the independent third-party assessment of IND FDA-sponsor communication practices. | Enhancing Regulatory Science and Expediting Drug Development | 8/11/2020 |
| 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 |
| Instructions for Use - Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products - Content and Format | Draft Guidance | Draft guidance providing recommendations for developing the content and format of an Instructions for Use (IFU) document. | Enhancing Regulatory Science and Expediting Drug Development | 7/10/2019 |
| Model Informed Drug Development Approaches for Immunogenicity Assessments | Public Workshop | Workshop on model informed drug development and best practices for immunogenicity and correlates of protection for evaluating biological products, including vaccines and blood products. | Enhancing Regulatory Decision Tools to Support Drug Development and Review | 6/9/2021 |
| Patient-Focused Drug Development: Collecting Comprehensive and Representative Input | Final Guidance | Final guidance describing approaches to collecting comprehensive and representative patient and caregiver input on burden of disease and current therapy. (Draft guidance published 6/12/2018) | Enhancing Regulatory Decision Tools to Support Drug Development and Review | 6/16/2020 |
| Patient-Focused Drug Development: Methods to Identify What Is Important to Patients Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders | Final Guidance | Final guidance to recommend methods for collecting patient input. (Draft guidance published 9/30/2019) | Enhancing Regulatory Decision Tools to Support Drug Development and Review | 2/25/2022 |
| PDUFA Quarterly Hiring Updates | Website Posting / Update | Quarterly hiring data to provide updates on the status of PDUFA-hired FTEs. | Set Clear Goals for Human Drug Review Program Hiring | Last Updated: 4/12/2022 |
| PFDD Public Repository | Website Posting / Update | Public repository for stakeholders which includes compendium of patient-focused drug development meeting resources and ongoing efforts on patient-focused drug development. | Enhancing Regulatory Decision Tools to Support Drug Development and Review | Last updated: 11/24/2020 |
| Population Pharmacokinetics | Draft Guidance | Draft guidance to assist sponsors of NDAs and BLAs in the application of population pharmacokinetic analysis. | Enhancing Regulatory Decision Tools to Support Drug Development and Review | 7/11/2019 |
| Promoting the Use of Complex Innovative Designs in Clinical Trials | Public Workshop | Public workshop to discuss various complex adaptive, Bayesian, and other novel clinical trial designs, with a particular focus on clinical trial designs for which simulations are necessary to evaluate the operating characteristics, and the acceptability of those designs in regulatory decision-making. | Enhancing Regulatory Decision Tools to Support Drug Development and Review | 3/20/2018 |
| Public Workshop: A Framework for Regulatory Use of Real-World Evidence | Public Workshop | Public workshop to discuss a framework for regulatory use of Real-World Evidence. | Enhancing Regulatory Science and Expediting Drug Development | 9/13/2017 |
| Publishing Target Timeframes | Website Posting / Update | Published target time frames for the 1) expected submission upload duration(s) and 2) timeframe between key milestones and notifications. | Improve the Predictability and Consistency of PDUFA Electronic Submission Process | 11/29/2021 |
| Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff | Guidance | Publication of new draft guidance which represents CDER’s and CBER’s current thinking on implementation of section 507 of the FD&C Act with respect to describing the process for requestors interested in qualifying DDTs and on taxonomy for biomarkers and other DDTs. | Enhance Drug Development Tools Qualification Pathway for Biomarkers | 11/24/2020 |
| Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry | Draft Guidance | Draft guidance to inform industry planning and participation in pre-IND meetings with FDA. | Ehancing Regulatory Science and Expediting Drug Development | 10/15/2018 |
| Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products | Draft Guidance | Draft guidance on how RWE can contribute to the assessment of safety and effectiveness in regulatory submissions. | Enhancing Regulatory Science and Expediting Drug Development | 9/28/2021 |
| 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 Capcaity Planning and Modernized Time Reporting | 3/30/2018 |
| Up-to-date Electronic Submission Documentation | Website Posting / Update | Up-to-date electronic submission documentation including, but not limited to, the submission process, the rejection process, validation criteria, software names and versions for eCTD validation and data validation tools. | Improve the Predictability and Consistency of PDUFA Electronic Submission Process | Last updated: 1/13/2017 |