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.

The following presentations explain important elements in the GDUFA III commitment letter regarding the Pre-ANDA Program. Where available, links to guidances, manuals of policy and procedures (MAPPs), and other resources are contained within the sections below. Note: FDA will add information and presentations to this page on an ongoing basis as more guidances and MAPPs become available.

Product-Specific Guidances (PSGs)

This section describes enhancements to the way FDA develops, prioritizes, and posts PSGs to support development of complex generic products. It also describes options for industry to request teleconferences and meetings related to PSGs.

Note: Information about teleconferences and meetings that are offered to applicants after an ANDA submission can be found on the ANDA Program Enhancements page.

Infographic GDUFA III – Summary of T-Cons and Meetings (PDF - 117 KB)

Product Development and Pre-Submission Meetings

This section describes enhancements to 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.

Infographic GDUFA III – Summary of T-Cons and Meetings (PDF - 117 KB)

Suitability Petitions

This section describes enhancements to the suitability petition process, including the establishment of new suitability petition goals beginning in FY2024, a new completeness assessment process, and new prioritization for suitability petitions.