GDUFA III Enhancements to the Pre-ANDA Program
The Pre-Abbreviated New Drug Application (Pre-ANDA) Program is designed to assist prospective generic drug applicants in developing more complete submissions, promote a more efficient and effective ANDA assessment process, reduce the number of assessment cycles, and facilitate approval of complex generic drug products. The terms of the GDUFA III commitment letter include a number of enhancements to the Pre-ANDA Program, including new scientific and product-specific guidance (PSG) meetings, new goals related to posting PSGs for complex generic drug products, and significant enhancements to the suitability petition process.
This page explains important elements in the GDUFA III commitment letter regarding the Pre-ANDA Program. When available, links to guidances, manuals of policy and procedures (MAPPs), and other resources, such as explanatory presentations, are included within the sections below.
Note: Information about teleconferences and meetings that are offered to applicants after an ANDA submission can be found on the ANDA Program Enhancements page.
On this page:
- Product-Specific Guidances (PSGs)
- Product Development and Pre-Submission Meetings
- Suitability Petitions
Product-Specific Guidances (PSGs)
FDA develops, prioritizes, and posts PSGs to support development of complex generic products. FDA also offers options for industry to request teleconferences and meetings related to PSGs.
Related Resources:
- Product-Specific Guidances
-
Infographic GDUFA III – Summary of Teleconferences and Meetings (PDF - 147 KB)
Product Development and Pre-Submission Meetings
FDA offers a variety of product development and pre-submission scientific meetings between industry and FDA. A pre-ANDA product development meeting is intended to provide a forum for a scientific exchange on specific issues (e.g., a proposed study design, alternative approach, additional study expectations, or questions) in which FDA will provide specific advice regarding an ongoing ANDA development program. A pre-submission scientific meeting is intended to provide an opportunity for an ANDA applicant to present unique or novel data or information to FDA that will be included in their submission.
Related Resources
- Guidance for industry: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA (February 2023)
- Guidance for industry: Competitive Generic Therapies (October 2022)
- Guidance for industry: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA (October 2022)
- MAPP: Evaluating Requests for and Conducting Product Development and Pre-Submission Pre-ANDA Meetings (October 2022)
- Infographic GDUFA III – Summary of Teleconferences and Meetings (PDF - 117 KB)
- Update on In-Person Face-to-Face ANDA Meetings
Suitability Petitions
Beginning in FY2024, FDA'S suitability petition process will establish new suitability petition goals, a new completeness assessment process, and new prioritization for suitability petitions.
Related Resources
- Suitability Petitions
- ANDA Suitability Petitions MAPP (PDF - 364 KB)