Well the negotiations for GDUFA II are completed, but what is in the works?  This morning a Federal Register Notice (FR) published announcing a public meeting on GDUFA II, but the notice itself provides some insight to the changes coming in GDUFA II and some big changes are coming.  The FDA plans to release its GDUFA II commitment letter (the bible of GDUFA) that will provide additional details on the program changes prior to the public meeting on October 21, 2016, but the FR document opens the window a bit as to the how, what, and why of GDUFA II.

Among the most notable changes are the following:

  • All ANDAs will fall under single cohort.
  • Faster review times – Expect a standard review of 10 months, but a priority review time of 8 months for those applications that qualify under MaPP 5240.3, Rev 2. Priority review would occur if the applicant provided a pre-submission facility correspondence 2 months prior to ANDA submission and it was found complete (this submission would identify all facilities utilized in the ANDA that may or may not require inspection).
  • 7 calendar day window for resolving potential refuse-to-file deficiencies.
  • Continue the practice of information requests (IRs) and discipline review letters (DRLs) and work through goal date, if imminent tentative approval would prevent forfeiture of 180-day exclusivity.
  • Strive to approve ANDA in first cycle (presupposes that applicants are able to respond to IRs and DRLs) and strive to approve first generics on the earliest lawful approval date.
  • Pre-ANDA meetings and mid-cycle review meetings for complex products.
  • Establish metrics for issuing product-specific guidance on complex products.
  • Commit to issuing product-specific guidance on 90% of products 2 years before the first lawful potential approval date.
  • Enhancements in controlled correspondence for complex issues, improve inactive ingredient database.
  • DMF review enhancements
  • Issue guidance on risk-based inspections and increase communication of issues relative to inspectional findings that would preclude ANDA approval.
  • Enhanced accountability and reporting with meaningful and robust monthly, quarterly, and annual reports to better gauge performance.
  • Fee structure enhancement:
    • Introduction of Annual program fee with three tiers based on the number of approved ANDAs held by it and its affiliates
    • Based on new program fee – FDA will eliminate the prior approval supplement fee.
    • No annual establishment fee to be paid until the establishment is named in an approved ANDA (eliminates payment of fees with no income).
    • Contract manufacturers who do not also manufacture ANDAs themselves will pay only 1/3 of the establishment fee that ANDA manufacturer’s pay.

Additional details will be disseminated prior to the October 21, 2016 meeting, but needless to say, GDUFA II will look much different than GDUFA I.  Click here to see the complete FR notice.