Navigating FDA OMOR Meetings: A Comprehensive Guide to Type X, Y, and Z Meetings for OTC Drug Sponsors

As Over-The-Counter (OTC) drug sponsors prepare for the three meeting types associated with US Food & Drug Administration (FDA) OTC Monograph Order Request (OMOR) submissions, the right regulatory strategists can guide your team through the steps common to each of these interactions including meeting requests, briefing documents, and meeting participation.

These three distinct types of meetings, as outlined in the FDA’s Draft Guidance for Industry Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs from February 2022, are described below. These meetings are classified as Type X, Type Y, and Type Z meetings, each of which is an OTC variant to classic FDA meeting types, A, B, and C, respectively.

To clarify each of these meetings, MMS developed a comprehensive guide on each type of FDA OMOR meeting including information on how our Regulatory Strategists can assist with preparation and attendance.

The Three Types of FDA OMOR Meetings

Type X Meetings

Purpose: Type X meetings are granted for critical issues that could significantly impact the development or manufacturing of a product. These meetings often involve discussions on urgent issues that require immediate attention or to address issues mentioned in a recently issued refuse-to-file letter. Type X meeting requests should be pre-approved by the FDA prior to submission of the request by contacting CDER-OMUFA-Portal@fda.hhs.gov. Remember: Your Type X Meeting Package must be submitted along with your Meeting Request!

How We Assist:

• Preparation: Preparation for a Type X meeting includes identifying and articulating the critical issues that need to be addressed. Drafting a clear and concise meeting request and briefing package that outlines the urgency and potential impact of the issues is a necessity.
• Strategy: Developing a strategy to effectively communicate the urgency of your concerns to the FDA, including formulating key discussion points and potential solutions based on available guidance and historical precedent.
• Follow-up: After the meeting, interpreting the FDA’s feedback and integrating it into the ongoing development plan will ensure timely and effective resolution of the issues. Preparation will also be made to anticipate additional correspondence with the FDA once formal minutes are received.

Type Y Meetings (Pre-OMOR Meeting)

Purpose: Type Y meetings are intended for discussions on significant changes or ongoing issues that could affect the product’s manufacturing process or quality but are not as urgent as those discussed in Type X meetings. Type Y meetings function as a milestone meeting for OTC development programs and should be approached similar to the traditional EOP2 or Pre-NDA meeting. These FDA OMOR meetings typically involve more routine, yet important, regulatory or compliance matters.

How We Assist:

• Preparation: Prepare relevant questions, your meeting request, and the necessary briefing documentation for Type Y meetings to ensure that all significant changes or ongoing issues are clearly articulated.
• Strategy: Develop a comprehensive strategy for presenting the development program, plans for the OMOR submission format and content, and issues in development to the FDA. This includes preparing responses to anticipate questions or concerns that may be raised.
• Documentation: Ensure that all relevant data and information are accurately documented and presented in a manner that supports the OMOR and all key messaging.

Type Z Meetings

Purpose: Type Z meetings are less common and generally reserved for discussions on less critical issues or for administrative purposes. These meetings often focus on routine or procedural aspects of the submission and all other elements that are not captured as part of Type X or Type Y meetings.

How We Assist:

• Preparation: For Type Z meetings, we help in organizing and preparing the documentation for routine or administrative discussions.
• Strategy: Ensure that all necessary procedural matters are addressed and provide guidance on how to effectively communicate your less critical issues.
• Documentation: Ensure that all relevant administrative details are accurately prepared and submitted to facilitate a smooth meeting process.

How MMS Can Enhance Your OMOR Meeting Experience

Partnering with MMS for OMOR meetings provides several benefits, as follows:

• Expertise and Experience: Our regulatory strategists have extensive experience with FDA OMOR meetings and can provide valuable insights into the specific requirements and expectations for each type of meeting.
• Efficient Preparation: We streamline the FDA OMOR meeting preparation process, ensuring that all necessary documentation and meeting materials are prepared and tailored to your OTC development program.
• Strategic Support: Our team has an extensive history of developing effective strategies for presenting meeting content, addressing FDA feedback, and implementing follow-up actions.
• Comprehensive Assistance: From initial preparation to meeting attendance to post-meeting follow-up, we provide end-to-end support to help you navigate the complexities of FDA OMOR meetings.

By leveraging MMS expertise and resources, you can approach an FDA OMOR meeting with confidence, ensuring that your OTC development program continues in an effective and efficient manner. For questions regarding FDA OMOR meetings, email info@mmsholdings.com and we will connect you with an expert.

This article was drafted by Ritchie Patton, Associate Director of Regulatory Strategy at MMS.