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  5. Completed PDUFA VI Deliverables
  1. Prescription Drug User Fee Amendments

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
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
Adaptive Design for Clinical Trials of Drugs and Biologics Draft Guidance  Draft guidance on complex adaptive trial designs. Enhancing Regulatory Decision Tools to Support Drug Development and Review 9/28/2018
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  
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
BQ submissions Website Posting / Update List of current BQ submissions. Enhancing Regulatory Decision Tools to Support Drug Development and Review Last Updated: 9/25/2018
CBER-CDER Data Standards Program Action Plan (version 3.4) Public Report Quarterly update to the data standards action plan. Enhance Transparency and Accountability of FDA Electronic Submission and Data Standards Activities 1/18/2019
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: 4/30/2019
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
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: 3/4/2019
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
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: 4/5/2019
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 8/2/2018
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
Five-Year Financial Plan Fiscal Years 2018-2019-2020-2021-2022, 2018 Version, for PDUFA 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 Report 2019 update to FDA's five-year financial plan. Financial Transparency and Efficiency 5/31/2019
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
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
Joint Quarterly Meetings to Enhance Transparency and Accountability of FDA Electronic Submission and Data Standards Activities Public Meeting Quarterly joint meetings to address challenges with electronic submisisons. Enhance Transparency and Accountability of FDA Electronic Submission and Data Standards Activities Last Updated: 01/04/2019
Patient-Focused Drug Development: Collecting Comprehensive and Representative Input Draft Guidance Draft guidance describing approaches to collecting comprehensive and representative patient and caregiver input on burden of disease and current therapy. Enhancing Regulatory Decision Tools to Support Drug Development and Review 6/12/2018
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: 5/9/2019
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 Last updated: 4/8/2019
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
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 10/31/2017