GDUFA II includes a pre-ANDA program designed to assist applicants to develop more complete submissions, promote a more efficient and effective ANDA review process, and reduce the number of review cycles and facilitate approval of complex generic products.  The program features product development, pre-submission and mid-review cycle meetings to help clarify regulatory expectations early in product development and during application review. 

GDUFA II includes goals for FDA to issue certain product-specific guidances.  Product-specific guidances identify the methodology for developing generic drugs and generating evidence needed to support generic approval.  Other pre-ANDA elements include enhancements regarding controlled correspondence, regulatory science, safety determination letters, and the Inactive Ingredient Database.

As part of the GDUFA II commitments, FDA issued a draft guidance, Formal Meetings Between FDA and ANDA Applicants of Complex Products. This guidance outlines the enhanced pathway for complex products, including product development meetings, pre-submission meetings, and mid-review cycle meetings.

FDA also committed to:

• Update the Inactive Ingredient Database to allow queries for maximum daily intake and maximum daily exposure (October 1, 2020); and
• Hold annual public workshops to request input on GDUFA II Regulatory Science Initiatives, and issue annual reports regarding the extent to which GDUFA regulatory science-funded projects support generic drug product development.

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

Transcript | Slides (PDF - 120KB)

Pre-Submission Meetings 

Transcript | Slides (PDF - 117KB)