FDA finalizes guidance on formal meetings with OTC sponsors
The US Food and Drug Administration (FDA) on Monday released final guidance detailing the procedures for holding formal meetings between sponsors of over-the-counter (OTC) monograph drugs and the agency. This update revises the criteria for the types of meetings that sponsors can request and introduces hybrid meetings as an additional option for consultations with FDA.
The guidance replaces a draft version issued on 22 February 2022. (RELATED: FDA drafts guidance on formal meetings with OTC sponsors, Regulatory Focus 2 February 2022)
The guidance outlines the principles of effective meeting management and provides standardized procedures for requesting, preparing for, and documenting formal meetings with the FDA. Issuance of this guidance also fulfills the requirements of the OTC Monograph Drug User Fee Program (OMUFA), which directed the FDA to establish procedures and policies for these meetings.
Meetings are classified into three categories: Type X, Type Y and Type Z. Type X meetings are focused on “otherwise stalled” OTC monographs, or products that have received a refuse-to-file letter. Type Y meetings are held for milestone discussions regarding an OTC monograph that is in development. Type Z meetings encompass all other discussions that do not fit into Type X or Type Y.
The final document broadens the type of development programs that can be requested for a Type Y meeting. It now includes pre-investigational new drug application (pre-IND) meetings. In this category, a meeting requester may ask for a meeting before submitting an IND.
FDA said this change was meant to accommodate commenters’ concerns that FDA “was limiting the number of Type Y meetings, which could affect OTC monograph order development.”
Other types of meetings available include those for overall data recommendations and pre-OMOR [monograph order request] submission meetings.
The revision introduces a new format for formal meetings that includes both hybrid and in-person options. In these meetings, core attendees from the FDA and the meeting requester will participate in person, while non-core participants can join virtually.
The other types of meetings include virtual face-to-face (video conference), teleconference, and written responses only (WRO).
The guidance states that “individuals expected to have a more peripheral role (e.g., individuals who may be called to comment on a single question) may participate virtually. If core meeting requester personnel are suddenly unable to attend the in-person meeting due to illness or unexpected travel issues, they can join the meeting virtually. If core meeting requester personnel are not planning to attend in person, the meeting should be requested as a virtual face-to-face meeting.”
Additionally, FDA added a new section explaining the process for meeting requesters to submit clarifying questions about the information in the meeting minutes or the WRO after they have received them. This responds to questions from commenters.
The revision states that “to facilitate a meeting requester’s understanding of FDA feedback from meeting discussions or a WRO, the meeting requester may submit clarifying questions to FDA within 30 calendar days following receipt of the meeting minutes or written response. Only questions of a clarifying nature on information in the meeting minutes or written response should be submitted (e.g., to confirm information in minutes or in a written response issued by FDA) rather than new issues, new questions, or new proposals. FDA has discretion to determine whether the questions are in scope.”
