GDUFA II Videos and Resources
Increasing consumer access to safe high-quality and affordable generic drugs is a top priority at FDA. In recent years, with the help of user fees from industry and the traditional budget appropriations received from Congress, FDA has approved record numbers of generic drug applications. The Generic Drug User Fee Amendments (GDUFA) were reauthorized and signed into law by the President on August 18, 2017. The reauthorization, known as GDUFA II, is in effect from October 1, 2017 through September 30, 2022.
In brief videos on this page, FDA staff highlight user fees and the new features in GDUFA II.
GDUFA by Dr. Kathleen “Cook” Uhl, Director, Office of Generic Drugs
In this video, Dr. Uhl shares a brief history of why generic drug user fees came to be, how user fees help the FDA and Industry, accomplishments in GDUFA I, and the features of GDUFA II. The 8 minute 39 second GDUFA video is broken into five segments or you can watch it in its entirety.
(2:49) Introduction: About GDUFA
(1:09) Why Generic Drug User Fees?
(1:22) How FDA Uses Fees
(1:08) GDUFA I Accomplishments
(2:10) Features of GDUFA II
GDUFA II Features
- GDUFA Overview
- Pre-ANDA Program for Complex Products
- Type II Drug Master Files (DMF) Update
- Performance Goals
- Goals Integration
- Review Status Updates
- Post Complete Response Letter (CRL) Meeting
- Requests for Reconsideration
- Review Classification
Pre-ANDA Program for Complex Products in GDUFA II
Learn about the three types of meetings for ANDA applicants seeking to develop generic versions of complex products: Product development meetings, Pre-submission meetings, and Mid-review cycle meetings.
Product Development Meetings
| VideoTranscript | Slides (PDF - 120KB)
| VideoTranscript | Slides (PDF - 117KB)
Mid-Review Cycle Meetings
| WebinarSlides (PDF - 252KB)
Type II Drug Master Files (DMF) Update
This presentation covers changes and new features related to Type II DMFs for Active Pharmaceutical Ingredients (API).
| VideoTranscript | Slides (PDF - 126KB)
Review important review goal dates in GDUFA II, what you need to know if you are an FDA reviewer or applicant, and what to expect during review cycles.
| VideoTranscript | Slides (PDF - 134KB)
Review how the new goal structure, review classification process, information requests (IRs), discipline review letters (DRLs), and mid-review cycle meetings are operationalized in GDUFA II.
| VideoTranscript | Slides (PDF - 217KB) | Review Definitions (PDF - 90KB)
Review Status Updates
This presentation describes the process for requesting and receiving status updates through the ANDA review process in GDUFA II.
| VideoTranscript | Slides (PDF - 309KB)
Post Complete Response Letter Meetings
This presentation outlines the step-by-step process for a successful Post Complete Response meeting request.
| VideoTranscript | Slides (PDF - 109KB)
Requests for Reconsideration
This video describes what is new and what has changed in GDUFA II for Requests for Reconsideration.
| VideoTranscript | Slides (PDF - 128KB)
Learn about review classification for ANDAs and the difference between standard versus priority review.
| WebinarSlides (PDF - 77KB)
- GDUFA II Commitment Letter
- Generic Drug User Fee Amendments (GDUFA)
- GDUFA Glossary
- GDUFA Guidances and MaPPs
- GDUFA Implementation Activities