October 3, 2017
Authored and Edited by Glen Cheng, M.D.; Linda A. Wadler
On October 3, 2017, FDA released a Draft Guidance for Industry titled “Formal Meetings between FDA and ANDA Applicants of Complex Products under GDUFA.” The Guidance is intended to assist ANDA applicants for complex products in requesting and conducting formal meetings with FDA, as contemplated in the reauthorization of the Generic Drug User Fee Amendments for Fiscal Years 2018-2022 (GDUFA II).
“Complex products” are defined as:
Formal meetings between FDA and ANDA applicants or prospective ANDA applicants of complex products are intended to facilitate development of complex products that may be submitted in an ANDA. The Guidance reviews the following topics: (1) types of formal meetings contemplated by FDA; (2) the GDUFA II performance goals; (3) meeting requests and the FDA’s assessment of meeting requests; (4) rescheduling and canceling product development and pre-submission meetings; (5) content and submission of meeting packages; (6) pre-meetings and communications with requesters for meetings; (7) procedures for the conduct of meetings; (8) documentation and meeting minutes; and (9) resolution of disputes about meeting minutes.
Meeting Types. The Guidance contemplates three types of formal meetings: product development meetings, pre-submission meetings, and mid-review-cycle meetings.
Product development meetings provide for discussion of “specific scientific issues or questions (e.g., a proposed study design, alternative approach, or additional study expectations),” regarding an ongoing ANDA development program. FDA will grant a product development meeting if the requested meeting concerns development of a complex product for which FDA has not issued a product-specific guidance, or concerns an alternative equivalence evaluation for a complex product for which FDA has issued a product-specific guidance. FDA may grant a product development meeting, dependent on FDA’s resources, if the meeting concerns complex product development issues other than those specified above. The FDA will not grant the product development meeting if the prospective ANDA applicant does not submit a complete meeting package, if controlled correspondence would adequately address the questions, or if a meeting would not significantly improve ANDA review efficiency.
Pre-submission meetings for complex products provide for discussion of “the format and content of the ANDA to be submitted (e.g., data to support equivalence claims, types of data that will be contained in the ANDA).” Pre-submission meetings should be held approximately 6 months before submission of an ANDA, and during the meetings FDA will identify items or information that should be clarified before submission of the ANDA. The meeting, however, does not include substantive review or summary data or full study reports, and is “not an opportunity to determine whether the application is acceptable for filing.”
Mid-review-cycle meetings are optional, may only be initiated by the FDA, and are only held during the first review cycle with ANDA applicants that have participated in a prior product development or pre-submission meeting. During these meetings, FDA may discuss issues or possible deficiencies identified during review of the ANDA.
GDUFA II Performance Goals. The Guidance lists certain performance review goals under GDUFA II that FDA has committed to meet concerning the timing of grant or denial decisions on meeting requests and scheduling of the product development meetings and pre-submission meetings for complex products. The FDA has not specified performance review goals regarding mid-cycle-review meetings.
Meeting Requests and FDA’s Assessment of Meeting Requests. The Guidance specifies the information that ANDA applicants or prospective ANDA applicants for complex products should submit in meeting requests. In assessing meeting requests, FDA will notify the applicant regarding whether the meeting is denied or granted. The Guidance states that “[d]enials will be based on a substantive reason, not merely on the absence of a minor element of the meeting request or meeting package items.” Examples of reasons for meeting denials include where the product does not meet the criteria for a complex product, or where a meeting is premature for the stage of product development due to insufficient data. If FDA grants a meeting, “FDA will schedule the meeting by determining the date, time, length, place, and expected FDA participants.”
Meeting Package Content. The meeting package for both a product development meeting and a pre-submission meeting should be submitted concurrently with the meeting request. Among other items, the meeting package should include a brief history and current status of product development, a brief statement summarizing the purpose of the meeting, a proposed agenda, including estimated times for each agenda item, and a list of questions for discussion including a brief explanation of the context and purpose of each question and any supporting rationale or data. The level of detail for the data “should be appropriate to the meeting type requested and the product development stage.”
Pre-Meeting Communications and Meeting Procedures. The FDA may send preliminary written comments to the prospective ANDA applicant five calendar days before the meeting. These preliminary written comments and any other pre-meeting communications between prospective ANDA applicants and FDA “can serve as a foundation for discussion or as the final meeting responses.” Preliminary responses should not generate the submission of new questions as new questions “will not be entertained at the meeting.” Preliminary written comments should not be construed as final unless there is agreement that no further discussion is necessary or there is agreement that a particular question is resolved. With respect to the meeting itself, presentations by the prospective ANDA applicant/ANDA applicant are generally not needed. Any planned presentation should be discussed ahead of time with the FDA. Before the end of the meeting, the prospective ANDA applicant/ANDA applicant will be asked to summarize important discussion points, agreements, clarifications and action items.
The Guidance also contains examples of circumstances necessitating the rescheduling or cancellation of a product development or pre-submission meeting, procedures for documentation and meeting minutes and resolution of disputes about meeting minutes, and a helpful Appendix summarizing the scope and criteria for meetings for complex products under GDUFA II.
FDA’s Draft Guidance can be found here.
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