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Transcript: GDUFA II Pre-ANDA Program Pre-Submission Meetings

Hello, I am Robert Lionberger, the director of the Office of Research and Standards in the Office of Generic Drugs. This is a second video on the GDUFA II pre-ANDA meeting system, so please watch the video on the product development meetings before watching this one.

The pre-ANDA program is new in GDUFA II and it’s designed to accelerate access to generic versions of complex products. Meetings between FDA and ANDA applicants are a critical step toward meeting these goals.

GDUFA II describes three types of meetings for prospective ANDA applicants seeking to develop generic versions of complex products: Product development meetings, Pre-submission meetings, and Mid-review-cycle meetings. Product development meetings were discussed in detail in the Product Development Meetings video.  This time, we will focus on pre-submission meetings and mid-review-cycle meetings.

The pre-submission meeting provides a prospective applicant the opportunity to discuss an ANDA to be submitted within the next year. At this meeting, FDA can give advice that will support efficient review and improve the chance of first cycle approval. For example, FDA can identify items or information that should be clarified before submitting an ANDA. FDA will also use this meeting to share information from product development meetings with the ANDA review team, and prepare for unique review issues.

In GDUFA II negotiations, FDA and industry agreed that FDA will generally grant pre-submission meetings if an applicant has already had a product development meeting. FDA may grant a pre-submission meeting to prospective applicants that did not have a product development meeting if, in FDA’s judgment, the pre-submission meeting would improve review efficiency and resources are available.

To request any type of meeting, you need to take several administrative steps. First, request a pre-assigned ANDA number. This will help us track your interactions with FDA all the way to approval. Second, with your pre-assigned ANDA number, sign up to use the CDER Direct NextGen Collaboration Portal, or simply The Portal, where you can submit the meeting request.

A pre-submission meeting request should contain an outline of the unique, novel or complex aspects of your upcoming submission that you will present at the meeting. If you have specific questions, provide appropriate background material and data related to those questions.

FDA will evaluate the meeting request and respond within the GDUFA II goal date.  For fiscal years 2018 and 2019, FDA will grant or deny the meeting request within 30 days of receipt. For fiscal years 2020 through 2022, FDA will grant or deny the meeting request within 14 days of receipt. FDA will then conduct the pre-submission meeting within 120 calendar days from the date the meeting was granted.  You can check the status of your meeting requests through the portal.

The Office of Regulatory Science project manager is your point of contact for the meeting process.  During the review of your meeting package, FDA staff will identify representatives of the ANDA review team and other experts, as appropriate, to participate in the pre-submission meeting. FDA will communicate the results of the product development meeting or other pre-ANDA interactions to the review team before your meeting.

If you included questions with your meeting package, you will receive preliminary written comments 5 calendar days before the meeting. At this time, you should also submit your final meeting slides and agenda to the portal.

On the meeting day, FDA staff will listen to your presentation about the unique, novel or complex aspects of your upcoming submission. FDA staff will then provide feedback on how to present the information in your submission. This will enable an efficient review and increase the potential for a first cycle approval. FDA staff will also discuss the written responses to your questions. FDA will not provide a substantive review of summary data or full study reports during this meeting.

After the meeting, FDA will issue official minutes within 30 days. If you’d like FDA to take your perspective into consideration, you can submit your meeting summary via the portal.  Remember, however, that FDA minutes are the official record of the meeting.

After your pre-ANDA meetings and after using the same pre-assigned ANDA number to submit your ANDA through the portal, the regulatory project manager will contact you to arrange a mid-review cycle teleconference.

Pre-Submission meetings are a new part of GDUFA II. They are intended to accelerate access to generic versions of complex products by making the ANDA review more efficient. We believe this tool will help reduce the number of review cycles necessary to obtain ANDA approvals of complex products.   Thank you.

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