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# FDA Finalizes Guidance on Formal Meetings for OTC Monograph Drugs
- URL: https://www.fdaweb.com/fda-finalizes-guidance-on-formal-meetings-for-otc-monograph-drugs/
- Published: 2026-07-13T12:00:00.000Z
- Updated: 2026-09-14T13:42:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161443

FDA has issued final guidance establishing recommendations for formal meetings between the agency and sponsors or requestors developing over-the-counter (OTC) monograph drugs, providing a standardized framework for obtaining regulatory advice throughout product development. The guidance, “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs,” outlines procedures for requesting, scheduling, conducting and documenting meetings related to OTC monograph order submissions under Section 505G of the Federal Food, Drug, and Cosmetic Act.

FDA says the [guidance](https://www.fda.gov/media/155864/download?ref=fdaweb.com) is intended to promote consistent meeting management practices and help ensure that meetings are scheduled in a timely manner, conducted efficiently and appropriately documented. It fulfills several statutory requirements established under the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act, which overhauled the regulation of OTC monograph drugs by replacing the decades-old rulemaking process with an administrative order system. It also incorporates meeting management commitments included in the Over-the-Counter Monograph User Fee Program (OMUFA II) performance goals for fiscal years 2026-2030.

The guidance applies to formal meetings involving OTC monograph drugs marketed without approved new drug applications, including discussions on studies needed to support OTC monograph order requests (OMORs), broader regulatory issues affecting OTC monograph drugs, and development programs for new OTC monograph products. It also covers meetings related to investigational new drug applications (INDs) intended to support determinations that a nonprescription drug is generally recognized as safe and effective (GRASE).

FDA categorizes formal meetings into three types based on the issues being discussed and the urgency of the request, such as:

- **Type X meetings** are reserved for urgent matters requiring immediate agency attention, such as stalled development programs following a refuse-to-file letter, significant safety issues involving marketed or investigational OTC monograph drugs, clinical hold discussions for certain INDs, and formal dispute resolution meetings. FDA recommends that sponsors contact the agency before submitting a Type X meeting request to determine whether the request is appropriate.
- **Type Y meetings** are intended for key development milestones. These include pre-IND meetings, overall data recommendation meetings to discuss evidence needed to support a GRASE determination or an OTC monograph order request, and pre-OMOR submission meetings. During pre-OMOR meetings, sponsors can present summaries of supporting data, discuss the format and content of their submission, obtain FDA feedback on filing readiness, and discuss the anticipated submission date and appropriate OMOR tier designation. FDA recommends holding these meetings at least three months before a planned OMOR submission.
- **Type Z meetings** include all other formal meetings that do not qualify as Type X or Type Y.

The agency notes that FDA review staff conduct numerous formal meetings each year with companies developing OTC monograph products and said standardized procedures are intended to improve the consistency and effectiveness of those interactions.