USFDA Guidance: Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter (OTC) Monograph Drugs

Before submitting an Over-the-Counter (OTC) Monograph Order Request (OMOR) or advancing the development of an OTC monograph drug, early engagement with the U.S. Food and Drug Administration (FDA) can help sponsors clarify regulatory expectations, discuss scientific evidence, and address potential development challenges. Structured interactions with the Agency allow sponsors to obtain timely feedback, improve development planning, and support efficient regulatory decision-making.

To support this process, the FDA published the Guidance for Industry – Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs, which establishes standardized procedures for requesting, preparing, conducting, and documenting formal meetings related to OTC monograph drugs regulated under section 505G of the Federal Food, Drug, and Cosmetic (FD&C) Act.

What is an OTC Monograph?

An OTC monograph is a regulatory framework established by the U.S. Food and Drug Administration (FDA) for certain nonprescription (over-the-counter) drugs. These are drugs that can be marketed without an approved new drug application (NDA) if they meet the conditions outlined in the relevant OTC monograph and all other applicable requirements.

Why This Guidance Is Important

Formal meetings provide sponsors and requestors with an opportunity to obtain FDA advice on scientific, regulatory, and development issues throughout the OTC monograph lifecycle. The guidance introduces standardized meeting procedures, defined timelines, and consistent documentation practices that improve communication and facilitate timely regulatory decisions.

Scope of the Guidance

The guidance applies to formal meetings between FDA and sponsors or requestors of OTC monograph drugs, including organizations representing their interests. It covers discussions related to OTC Monograph Order Requests (OMORs), regulatory matters, and the development of new OTC monograph drugs, including certain investigational new drug (IND) studies intended to support a determination that a product is Generally Recognized as Safe and Effective (GRASE).

The guidance does not apply to meetings associated with New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs).

Types of Formal Meetings

The guidance defines three categories of formal meetings based on their purpose and urgency.

• Type X Meetings

  Type X meetings are intended for urgent situations requiring immediate FDA interaction. These include stalled development programs, significant safety concerns, clinical holds for applicable INDs, and formal dispute resolution. Sponsors are encouraged to discuss the appropriateness of a Type X request with FDA before submission.

• Type Y Meetings

  Type Y meetings support key development milestones and include:

  • Pre-IND meetings

  • Overall Data Recommendation meetings

  • Pre-OMOR submission meetings

  These meetings allow sponsors to discuss development strategies, recommended data packages, OMOR preparation, submission readiness, proposed timelines, and FDA expectations before filing an OTC Monograph Order Request.

• Type Z Meetings

  Type Z meetings include all other formal meetings that do not qualify as Type X or Type Y and provide flexibility for additional scientific or regulatory discussions during product development.

Meeting Formats

FDA supports four meeting formats:

• Hybrid in-person meetings

• Virtual face-to-face meetings

• Teleconferences

• Written Response Only (WRO)

The Agency determines the most appropriate format based on the complexity of the discussion topics and the questions submitted.

Meeting Requests

Meeting requests must be submitted electronically through the CDER NextGen Portal. They should include product details, meeting objectives, proposed agenda, discussion questions, preferred meeting dates, requested meeting format, and attendee information.

FDA recommends limiting requests to no more than ten clearly defined questions to ensure productive discussions and efficient meeting management.

FDA Review and Meeting Timelines

FDA reviews each request to determine whether the meeting will be granted and identifies the appropriate meeting type and format.

Current OMUFA performance timelines include:

• Type X: FDA response within 14 calendar days; meeting scheduled within 30 days.

• Type Y: FDA response within 14 calendar days; meeting scheduled within 70 days.

• Type Z: FDA response within 21 calendar days; meeting scheduled within 75 days.

Meeting requests may be denied if they are premature, inadequately supported, duplicative of previous meetings, or when applicable OTC monograph user fees remain unpaid.

Meeting Package

A comprehensive meeting package is essential for productive discussions. It should include background information, development history, study summaries, meeting objectives, agenda, attendee lists, discussion questions, and supporting scientific data relevant to the topics being discussed.

Meeting packages must be submitted electronically within the timelines specified for each meeting type to allow adequate FDA review and preparation.

Preliminary Responses

For most Type Y and Type Z meetings, FDA provides preliminary written responses approximately five calendar days before the scheduled meeting. Sponsors should review these responses and determine whether further discussion is still necessary. If the preliminary responses sufficiently address all questions, the written responses may serve as the official meeting record.

Rescheduling, Meeting Conduct and Minutes

Meetings may be rescheduled when additional review time is required, meeting packages are delayed, essential attendees become unavailable, or significant changes are made to the submitted questions. Meetings may also be cancelled if meeting packages are inadequate or if FDA's preliminary responses fully resolve the discussion topics.

FDA chairs each meeting and documents the key discussions, agreements, action items, and outcomes in official meeting minutes, which are generally issued within 30 calendar days after the meeting. Sponsors may submit clarification questions related to the meeting minutes within 30 calendar days, and FDA generally provides written responses within 60 calendar days.

Joint Meetings

The guidance also establishes procedures for joint meetings involving multiple sponsors or requestors with common regulatory interests. A single point of contact should coordinate all communications with FDA, while the meeting package should identify all participating organizations and specify any confidential discussion topics that should be excluded from the meeting.

Confidentiality

Although the OTC monograph administrative order process is generally transparent, certain confidential commercial information submitted to FDA remains protected under applicable statutory provisions. The guidance also explains when information submitted in connection with an OTC Monograph Order Request may become publicly available during the administrative order process.

By defining meeting types, timelines, submission requirements, documentation standards, and communication practices, the guidance promotes consistent regulatory interactions and supports efficient development and evaluation of OTC monograph drugs.

References

Guidance for Industry – Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs