After months of negotiations, the FDA published a proposed Commitment Letter for GDUFA IV, which will outline the OGD and Industry’s agreements regarding all aspects of the ANDA review and approval process. The proposed commitment letter can be found here. The 48-page document addresses all issues that have undergone negotiations regarding the proposed new iteration of GDUFA IV scheduled to take effect on October 1, 2028.

In a Federal Register Notice (here), “FDA is announcing a hybrid public meeting to discuss proposed recommendations for the reauthorization of GDUFA, which authorizes FDA to assess and collect user fees to support human generic drug activities, which are defined under the FD&C Act, to include the activities necessary for the review (also called “assessment”) of generic human drug applications and Type II active pharmaceutical ingredient (API) drug master files (DMFs), and for conducting inspections related to generic drugs, and to engage in other related activities. The current authorization of the program (GDUFA III) expires at the end of September 2027. Without new legislation, the FDA will no longer be able to assess and collect user fees to help fund human generic drug activities for future fiscal years”.

There is a 30-day comment period which will enable you to provide your views on the issues raised in the proposed letter. Please use this time to make comments as this may be your last chance prior to the public hearing and before the letter goes to Congress for approval.

The document covers:

  • SUBMISSION ASSESSMENT PERFORMANCE GOALS – e.g., including those for ANDA, amendments, supplemental applications, drug master files, controlled correspondence, etc.
  • ORIGINAL ANDA ASSESSMENT PROGRAM ENHANCEMENTS
  • SUITABILITY PETITIONS, PRODUCT SPECIFIC GUIDANCE, AND APPLICATION-RELATED MEETINGS
  • ADDITIONAL PROGRAM ENHANCEMENTS – including those related to the inactive ingredient database, additional maximum daily does information, updated table formats for Bioequivalence study summary tables, BE site information, drug substance impurity structures, information for the presentation pharmacokinetic study data from individual tables, regulatory science enhancement
  • DMF ASSESSMENT PROGRAM
  • FACILITIES – including communications regarding inspections, an inspections classification database, post PAI meetings, post warning letter meetings, generic drug manufacturing re-inspections, as America First incentives for some Domestic manufacturers.
  • USER FEE RESOURCE MANAGEMENT
  • GUIDANCE AND MAPPS
  • PERFORMANCE REPORTING
  • SECTION ON DEFINITIONS

There is obviously much more detail in the proposed commitment letter, so be sure to read it and provide the FDA with your comments through the specified docket. Remember that once finalized, this will be the OGD bible of commitments for a five-year period commencing on October 1, 2028.