Formal Meetings Between the FDA and Sponsors of OTC Monograph Drugs

Key changes

The guidance details the procedures for requesting, scheduling, and conducting formal meetings. It finalizes the draft guidance issued in February 2022 and incorporates changes based on public comments, including those related to meeting requests and the use of written responses.

PV impact

While primarily procedural for drug development, this guidance defines the communication channels for safety and regulatory discussions for OTC monograph drugs, which may involve safety signals or post-market requirements.

Exact policy details

Docket Number

FDA-2022-D-0080

Applies to: Applicable to formal meetings for OTC monograph drugs

Docket Number mentioned in the introduction · p. 1 · High · Source

Issuance Date

July 2026

Applies to: Date of guidance issuance

Date first introduced in the document · p. 1 · High · Source

Meeting Package Submission Timing

3 months before planned OMOR submission

Applies to: Relevant for Type Y meetings to ensure FDA feedback

The timing for pre-OMOR submission meetings is discussed in Section III.C. · p. 8 · High · Source

Formal Meeting Types

Type X, Type Y, Type Z

Applies to: Guidelines for formal meeting classifications with FDA

Section III outlines the definitions of meeting types · p. 4 · High · Source

User Fee Program for OTC Monograph Drugs

OTC Monograph User Fee Program (OMUFA)

Applies to: Regulatory compliance and user fee-related to OTC monograph drugs

Discusses the framework under which formal meetings are conducted · p. 6 · High · Source

Workflow rule impacts

Extracted documents

• Guidance for Industryhtmlhtml · high · 1 page
• Download the Final Guidance Documentpdfpdf_text · high · 25 pages
• Search for FDA Guidance Documentshtmlhtml · high · 1 page
• Advisory Committee Guidance Documentshtmlhtml · high · 1 page