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  5. GDUFA II Pre-ANDA Program
  1. Generic Drug User Fee Amendments

GDUFA II Pre-ANDA Program

The pre-ANDA program, first introduced in GDUFA II, is 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 GDUFA science and research, product-specific guidances (PSG), Pre-ANDA meetings, and controlled correspondences.

The Pre-ANDA meetings, new under GDUFA II, include product development, pre-submission, and mid-review cycle meetings to help clarify regulatory expectations early in product development and during application review.

Product-specific guidances identify the most appropriate methodology for developing generic drugs and generating evidence needed to support generic approval. Under GDUFA II, FDA also committed to goal dates for issuing certain product-specific guidances.

Other Pre-ANDA elements include enhancements regarding controlled correspondence, regulatory science, safety determination letters, and the Inactive Ingredient Database.

As part of our GDUFA II commitments, FDA has:

  • Published a 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.
  • Update the Inactive Ingredient Database to allow queries for maximum daily intake and maximum daily exposure
  • Held annual public workshops to request input on GDUFA II Regulatory Science Initiatives
  • Issued 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 product development meetings and pre-submission meetings for ANDA applicants seeking to develop complex generic drug products:

Product Development Meetings
 
 

Transcript | Slides (PDF - 120KB)

Pre-Submission Meetings 
 
 

Transcript | Slides (PDF - 117KB)

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