In GDUFA II, the FDA agreed to product development meetings, which provide for substantive discussions of specific scientific issues or questions, so that the FDA can provide prospective ANDA applicants with targeted advice.
In the Generic Drug User Fee Amendments for Fiscal Years 2018-2022 (GDUFA II), the FDA agreed to a series of meetings with prospective and current abbreviated new drug application (ANDA) applicants to facilitate the development of complex products. Complex products as defined in this guidance refer to: (1) products with complex active ingredients or complex dosage forms, (2) complex drug-device combination products and (3) other products where complexity or uncertainty concerning the approval pathway or possible alternative approach would benefit from early scientific engagement. In November 2020, the FDA published guidance for ANDA applicants of complex products submitting meeting requests to the FDA.
In GDUFA II, the FDA agreed to product development meetings, which provide for substantive discussions of specific scientific issues or questions, so that the FDA can provide prospective ANDA applicants with targeted advice. According to the FDA’s guidance, to ensure the FDA will grant a product development meeting, prospective ANDA applicants should submit a complete meeting package, ensure that a controlled correspondence would not adequately address the questions, and ensure that the meeting would significantly improve ANDA review efficiency.
In GDUFA II, the FDA also agreed to conduct pre-submission meetings with prospective ANDA applicants to provide an opportunity to discuss and explain the planned ANDA submission. In this meeting, the FDA will identify topics the applicant should clarify before submission of the ANDA. Prospective ANDA applicants of complex products may request a pre-submission meeting whether or not they had a product development meeting. The FDA will generally grant pre-submission meetings for prospective applicants that have had a product development meeting, and may grant pre-submission meetings to those that did not, if the FDA believes the pre-submission meeting would improve review efficiency.
Requests for product development and pre-submission meetings should be sent through the CDER Direct NextGen Collaboration Portal and include all of the following:
- Pre-assigned ANDA number
- Meeting type being requested
- Reference listed drug and its application number
- Dosage form, route of administration and strength
- A statement indicating whether the submission is being made by the prospective ANDA applicant or by a U.S. agent on behalf of the prospective ANDA applicant
- Contact person for the meeting
- The meeting package
A meeting package should clearly indicate that the prospective applicant is requesting a product development or pre-submission meeting and should include the following information for the FDA to assess the utility of the meeting:
- Pre-assigned ANDA number
- Established name
- Chemical structure
- RLD and application number
- Proposed indication(s)
- Dosage form, route of administration and dosing regimen
- A background section that includes a brief history and status of the development program
- A brief statement indicating how the product meets the criteria for a complex product
- A brief statement of the purpose and objectives of the meeting
- A list of all individuals who will attend the requested meeting from the ANDA applicant’s organization
- Suggested dates and times for the meeting
- The proposed format of the meeting (i.e., written response only, face-to-face or teleconference)
- A proposed agenda, including estimated times needed for discussing each agenda item
- A list of questions for discussion, grouped by discipline, as applicable, with each question clearly numbered
- Data to support discussion organized by discipline and question
Finally, in GDUFA II, the FDA agreed to mid-review-cycle meetings with ANDA applicants, which are to be held during the first review cycle with applicants who have participated in a prior product development or pre-submission meeting. The mid-review-cycle meetings give the FDA an opportunity to convey significant issues that were identified during review of the ANDA, ask the applicant clarifying questions about its submission, and outline recommended next steps.
Additional details and recommendations are included in the FDA’s guidance.
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