Hello, I am Robert Lionberger, the director of the Office of Research and Standards in the Office of Generic Drugs. In this presentation, I’ll walk you through the GDUFA II pre-ANDA meeting system and focus on the product development meeting available to prospective applicants submitting abbreviated new drug applications – or A.N.D.As – for complex generic drug products.
The pre-ANDA program is new in GDUFA II and it is 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.
The product development meeting is a scientific meeting on a specific issue for a complex generic product. FDA will provide advice and feedback to applicants on new or alternative approaches to demonstrating equivalence to the reference listed drug.
In GDUFA II negotiations, FDA and industry agreed that FDA will grant product development meetings if certain conditions are met. The meeting must concern a complex product that does not have FDA guidance for the reference product, or the applicant has an alternate approach to demonstrating bioequivalence to the complex reference product, such as in vitro replacement of clinical endpoint bioequivalence study. The package must be complete, and the questions should be beyond the scope of what a controlled correspondence could answer, as a new bioequivalence approach always is. Most importantly, the meeting is designed to improve ANDA review efficiency. So we will not be answering your questions about NDA submissions. These conditions ensure the meetings prioritize situations where there is no clear path for generics. If these conditions are not met, then FDA has the option of granting a meeting or directing the applicant to use other parts of the pre-ANDA program such as controlled correspondence.
A complex product is defined in the GDUFA II commitment letter and includes products with complex active ingredients, formulations, routes of delivery or dosage forms, complex drug-device combinations, or other products where complexity or uncertainty concerning the approval pathway or other alternative approach would benefit from early scientific engagement.
In order to request your product development meeting, you need to take several administrative steps: First, request and obtain 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, you can sign up for and use the CDER Direct NextGen Collaboration Portal, or simply The Portal, to submit your meeting request.
Remember that you must submit a complete meeting package. A complete meeting package contains clear and specific questions that are supported by appropriate data. The product development meeting is not a fishing expedition. It is for prospective ANDA applicants who are actively engaged in product development. FDA’s experience shows that data in the meeting package leads to more useful and practical discussion during the meeting.
There are different FDA staff members who will be involved in evaluating your meeting package: The signatory authority will make the final decision on granting your meeting. He or she also will oversee the process and is accountable for the outcomes of the meeting.
A project manager from the Office of Research and Standards, or ORS project manager, will be your point of contact and run the internal process.
And the meeting team lead will coordinate the technical content from all disciplines into a consistent response.
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 conduct the product development meeting within 120 calendar days from the date the meeting was granted. You can check the status of your meeting requests using the portal.
To evaluate your meeting package, FDA staff builds on the scientific foundation that comes from our GDUFA research program. In preparation for the meeting, FDA may request that you provide additional information. You can use the portal to submit your responses to these information requests.
FDA will provide preliminary written comments 5 calendar days before the product development meeting. Use these comments to prioritize your time with FDA. Focus on the questions that need more clarification. At this time, you should also submit your final meeting slides and agenda to the portal.
On the meeting day, you can expect interactive discussion with FDA about the questions posed and the data provided in your meeting package. Our goal is to assist your development program and move you towards submitting an ANDA. However, FDA cannot review any material presented at the meeting for the first time.
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. However, be advised that FDA minutes are the official record of the meeting.
Product development meetings are a new part of GDUFA II. They are intended to accelerate access to generic versions of complex products. We look forward to using these meetings to interact with industry to support innovative and efficient methods to demonstrate equivalence. Thank you and be sure to watch on the video on pre-submission meetings.