The Office of Generic Drugs has issued a guidance titled “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA” (here) that addresses OGD expectations, procedures for obtaining such meetings, and timeline for scheduling and having the meetings. As the FDA notes in the guidance: “FDA will only grant post-CRL meeting requests that pose questions to clarify identified deficiencies. Other issues, including questions requiring further Agency review, disputes about classification of complete response amendments or new information submitted by the applicant, will not be addressed in a post-CRL meeting.”
As a reminder, under GDUFA II goals, the FDA will schedule 90% post-CRL meetings within 10 days of receipt of the request and, if the request is granted, will conduct 90% of the meetings, within 30 days (or longer, at the request of the sponsor). Within 10 days of the receipt of a CRL, the applicant should submit the request for a post-CRL meeting (if necessary) and, according to the guidance, this request should address the following points:
- A list of proposed questions seeking clarification of the deficiencies identified in the CRL, grouped by discipline;
- A list of all individuals, with their titles and affiliations, who will participate in the requested meeting from the applicant’s organization and consultants;
- The requested format of the meeting—teleconference or written response. If the requested format of the meeting is a teleconference, the meeting request package should also include the following information:
- A proposed agenda outlining how the 30-minute time allotted for the post-CRL meeting should be apportioned to each proposed question.
- A list of specific review disciplines asked to participate in the requested teleconference.
The guidance discusses they type of meeting the Agency may grant and examples of the topics that will likely result in denial of the meeting request. It also includes information on rescheduling and/or canceling such meetings, as well as procedures for the conduct of the meeting and a description of how the meeting will be documented (the FDA minutes will be the official record of the meeting and the FDA will aspire to providing those minutes within 30 days of the meeting). There is also a brief section on dispute resolution.
This is an important guidance and, given the way controlled correspondence has been handled, firms should follow the instructions and format outlined in the guidance to assure the greatest chance of obtaining the meeting at the earliest time possible.