Hello, I'm LCDR Anh Bui, and I'm a Regulatory Project Manager Team Lead in the Office of Generic Drugs. I'll be going over the post complete response letter, or post-CRL, meeting requests in generic drug user fee amendments, or GDUFA II. I will address what's new and what's changed since GDUFA I and the impact on FDA and industry. Let's begin!!
As a reminder, post-CRL meeting requests are used by applicants who submit an abbreviated new drug application, or ANDA, to seek clarification concerning deficiencies identified in a complete response letter. Post-CRL meetings are available for both major and minor complete response letters and for first and subsequent review cycles.
In the GDUFA II Commitment Letter, FDA reauthorized and expanded its obligations and committed to scheduling and conducting post-CRL meetings within prescribed timeframes. Specifically, FDA will provide a scheduled date for 90 percent of post-CRL meetings within 10 calendar days of receipt of the meeting request. FDA will also conduct 90 percent of post-CRL meetings held on a FDA-proposed date within 30 calendar days of receipt of the meeting request. Note that under GDUFA II, days are counted in calendar days instead of business days.
Also in GDUFA II, a teleconference will be granted when requested by the applicant as long as all criteria are met per the guidance for industry titled "Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA." Consequently, an incomplete meeting package may be denied, and late submitted meeting request that is otherwise complete, may be granted with no goal dates.
A complete meeting request package should contain a list of proposed questions seeking clarification of the deficiencies identified in the complete response letter, grouped by discipline. It should also contain the requested format of the meeting, whether a teleconference or a written response. If the applicant is requesting a teleconference, the following information should also be included: a list of all individuals who will attend the meeting, with their titles and affiliations; a proposed agenda outlining how the 30-minute teleconference is allotted for each proposed question, and a list of review disciplines asked to participate in the teleconference.
So what is the impact of these GDUFA II changes? The new goal dates will offer a more predictable timeline for industry and timely communications. Additionally, the shift from U.S. business days to calendar days will help maintain consistency and improve tracking.
Lastly, granting teleconferences will provide the applicant with a better understanding into the deficiencies, and allow for an interactive discussion with FDA, and thereby decrease the need for follow-up meeting requests and potentially lead to a prompt resubmission of the complete response.
In GDUFA II, both FDA and ANDA applicants have distinct roles and responsibilities. The applicant is responsible for submitting a complete post-CRL meeting request package within the specified timeframe. Post-CRL meeting requests should only contain clarifying questions to deficiencies in the complete response letter. Questions not within scope of the complete response letter, such as dispute of an amendment classification, are not appropriate for post-CRL meeting requests and are subject to denial.
The Regulatory project managers (RPMs) and discipline project managers (PMs) for quality or labeling-only supplements are responsible for Identifying when a post-CRL meeting request package is submitted, triaging the request, and assigning it to the appropriate discipline. Collaborating with the review disciplines, when necessary, will help determine whether to grant or deny the post-CRL meeting request. The RPM or discipline PM will be looking to see if the meeting package is complete, if the meeting request was submitted after a CR letter, and if there are clarifying questions.
If a decision has been made to grant the meeting request, the RPM or discipline PM will schedule the teleconference and notify the applicant in writing. Also during this time, if it is decided to grant the teleconference, the RPM or discipline PM will schedule the internal meeting and establish due dates with disciplines for responses in order to collect all discipline responses in preparation for the teleconference.
During the teleconference, the RPM or discipline PM will facilitate the meeting and take meeting minutes. Once the minutes have been finalized, the RPM or discipline PM will issue the meeting minutes to the applicant.
RPM and discipline PM are responsible for keeping track of all goal dates and internal due dates for responses.
Review teams can include discipline PMs, reviewers, team leaders and/or division directors. Their responsibilities are as follows: making a decision to grant or deny the post-CRL meeting request within the specified timeframe; providing responses to questions by agreed upon date, and attending the meeting.
FDA will evaluate the contents of the post-CRL meeting request package to verify that it includes the requested information and determine whether the meeting request will be granted or denied.
A meeting request may be granted if a post-CRL meeting request has not already been submitted for the same complete response letter, and if the proposed questions seek clarification concerning deficiencies in the complete response letter, and if a complete meeting package is submitted.
FDA may deny a post-CRL meeting request if the proposed questions are not clarifying, are outside the scope of the deficiencies identified in the complete response letter; and require review from the Agency; and if the post-CRL meeting request is not submitted after issuance of a complete response letter, or the meeting package is not complete.
ANDA applicants can promote success by adhering to the guidance when submitting a post-CRL meeting request package.
As a reminder, rolling submission of questions is not appropriate, and requests outside the scope of a post-CRL meeting request should not be submitted. It is also helpful to send a courtesy copy of the meeting package to the RPM when submitting the meeting request.
Here are some of the resources available to applicants and FDA staff for additional information: The GDUFA II Commitment Letter, and Draft Guidance for Industry: "Post-Complete Response Letter Meetings between FDA and ANDA Applicants Under GDUFA."
So who are the contacts for post-CRL meeting requests? Depending on whether the meeting request is for an original ANDA or a supplement, the point of contact will differ.
For original ANDA applications, the primary point of contact will be the regulatory project manager assigned to the ANDA.
For prior approval supplements, the primary point of contact will be dependent upon on the disciplines involved. For labeling-only supplements, please contact the OGD labeling PM. For quality-only supplements, please reach out to OPQ's regulatory business process manager. If the supplement involves two or more disciplines, please contact the OGD RPM.
Thank you for your time and I hope you now have a better understanding about post-CRL meeting requests under GDUFA II.