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  1. Generic Drug User Fee Amendments

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. 

 
 

GDUFA (8:39)
Introduction: About GDUFA (2:49)
Why Generic Drug User Fees? (1:09)
How FDA Uses Fees (1:22)
GDUFA I Accomplishments (1:08)
Features of GDUFA II (2:10)

GDUFA II Features

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

Video | Transcript | Slides (PDF - 120KB)

Pre-Submission Meetings 

Video | Transcript | Slides (PDF - 117KB)

Mid-Review Cycle Meetings

Webinar | Slides (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).

Video | Transcript | Slides (PDF - 126KB)

Performance Goals

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.

Video | Transcript | Slides (PDF - 134KB)

Goals Integration

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.

Video | Transcript | 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.

Video | Transcript | Slides (PDF - 309KB)

Post Complete Response Letter Meetings

This presentation outlines the step-by-step process for a successful Post Complete Response meeting request.

Video | Transcript | Slides (PDF - 109KB)

Requests for Reconsideration

This video describes what is new and what has changed in GDUFA II for Requests for Reconsideration.

Video | Transcript | Slides (PDF - 128KB)

Review Classification

Learn about review classification for ANDAs and the difference between standard versus priority review.

Webinar | Slides (PDF - 77KB)

Related Resources

 

 

 

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