With the coming of GDUFA III, many guidance documents have been changed, and new guidances have been released to address new issues under GDUFA III.  We have published posts describing many of the changes and now the FDA has issued an updated guidance on prior approval supplements (PAS) (here).

The above‑cited guidance replaces the October 2017 guidance of the same name due primarily to a section explaining how the GDUFA III performance goals apply to:

  • A PAS subject to the refuse-to-receive (RTR) standards
  • A PAS that requires an inspection
  • A PAS for which an inspection is not required
  • An amendment to a PAS
  • Other PAS-related matters

Remember that in GDUFA I, fees were charged for PASs.  Those fees were eliminated with the reauthorization of GDUFA II and, under the current GDUFA III reauthorization, there are still no fees for PASs.  The FDA does, however, remind applicants that Type II active pharmaceutical ingredient (API) DMF holders are still subject to a DMF fee the first time that an initial letter of authorization references a DMF in an ANDA or PAS.  While the GDUFA III goal dates remain the same as in GDUFA II, there are some specific issues related to GDUFA III that are outlined in the guidance document.  Also, please remember that this guidance applies only to PASs submitted to ANDAs.

Please review the guidance document and the goal‑date charts to refamiliarize yourself with the FDA’s expectations, how PASs are treated, and how the review clock can change based on additional unsolicited amendments to a PAS.  There is also a decision chart that will leads you through the pathway to finding the goal date you should anticipate for your PAS.  Interestingly, there is not much discussion of the refuse‑to‑receive standards other than in the decision chart, which basically says that if a PAS is not complete, it will not be received by the OGD.