Today, the FDA released a final guidance titled Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA (here). Wading through the 26-page document is a bit of a chore, but there is a lot of useful information that will provide applicants with advice on what to do, when to do it, and how to address it if issuance of a new or revised Product Specific Guidance (PSG) impacts an application’s review timeframe (for instance, if a PSG is issued after a study is conducted and before submission or after an ANDA submission). The Agency provides advice on approaches that the sponsor should take when a change is made in a PSG at various times in the development process, just before submitting the ANDA, or after submission occurred.

Here are a few specific examples of situations in which the Agency provides its advice regarding various meeting types and issues.

  • “PSG teleconferences provide an opportunity for an applicant to obtain FDA’s feedback on the potential impact of a new or revised PSG on the applicant’s development program when the applicant has already commenced (i.e., the study protocol was signed by the study sponsor and/or the contract research organization) or completed an in vivo BE study.”
  • “When FDA publishes a new or revised PSG which includes a recommendation to conduct an in vitro BE study only and an applicant has already commenced or completed an in vivo BE study, FDA generally would consider the submission of the in vivo BE study as an acceptable approach to demonstrate BE.” “[A]pplicants in such a situation in general should not request a PSG teleconference”; however, the Agency suggests that supporting information be included in the submission that justifies the applicant’s approach. This may be a worry for the sponsor, especially if the new PSG is issued during the current review cycle, which could mean a lengthy delay in the FDA determining that the BE information is sufficient to support approval based on when in the review cycle the new guidance was published.
  • “After a pre-submission PSG teleconference has been held, a prospective ANDA applicant can request a pre-submission PSG meeting (if the ANDA has not been submitted), an ANDA applicant can request a post-submission PSG meeting (if the ANDA has been submitted), or an applicant can utilize the controlled correspondence (CC) process or request another meeting type, such as a pre-ANDA product development meeting, as appropriate, to seek further feedback from the FDA regarding an alternative BE approach to the recommendations in the PSG.”
  • The FDA notes that only one approach or request should be used at a time; for instance, if a sponsor submitted a CC and also asks for a pre-PSG telcon or other meeting request, the FDA will decide which approach is most appropriate, grant that request if appropriate, and deny any other requests that the sponsor has submitted. The bottom-line is, don’t shop for answers by making multiple submissions.
  • “After a pre-submission PSG teleconference has been held and before the ANDA is submitted, the prospective ANDA applicant can request a pre-submission PSG meeting. The purpose of the pre-submission PSG meeting is to provide a forum in which the prospective ANDA applicant can discuss the scientific rationale for an approach other than the approach recommended in the PSG to ensure that the approach complies with the relevant statutes and regulations.”
  • “After the ANDA has been submitted and a pre-submission PSG teleconference or a post-submission PSG teleconference has been held, the ANDA applicant can request a post-submission PSG meeting. The purpose of the post-submission PSG meeting is to provide a forum in which ANDA applicants can discuss the scientific rationale for an approach other than the approach recommended in the PSG to ensure that the approach complies with the relevant statutes and regulations.”
  • If your submission is in a current review cycle, the “FDA recommends that an ANDA applicant refrain from requesting the post-submission PSG meeting during the assessment cycle until after FDA has issued a discipline review letter (DRL) or a CRL to allow FDA to complete its scientific evaluation of the ANDA applicant’s submitted evidence of BE.”

The remainder of the guidance document discusses in detail what information should be included in the different meeting packages and when the meeting packages are to be submitted (the FDA indicates that meeting packages should be submitted along with the request for any telcon or meeting so the Agency can properly evaluate the request and determine whether or not to grant the meeting or suggest an alternative type of submission (e.g., CC)). In addition, the FDA notes that it typically will not provide preliminary written comments to PSG telcon requests but may provide them for PSG pre-submission and post submission meetings.

The guidance also outlines procedures for the conduct of the meeting, the provisions for an end-of-meeting summary, and documentation of the meeting and minutes of the meeting, as well as dispute resolution regarding disagreement with the FDA’s final meeting minutes. The FDA also notes that presentations are typically not needed because the pertinent information should be in the meeting packages. If the sponsor wants to make a presentation, they should discuss it with the FDA prior to the meeting. The FDA indicates that it will not extend meetings for sponsors to make presentations.

The devil is always in the details so be sure to fully understand the FDA’s expectations and follow the recommendations in the final guidance.