PV Bulletin

Formal Meetings Between the FDA and Sponsors of OTC Monograph Drugs

FDA issued a final guidance that defines procedures for formal meetings regarding OTC monograph drugs, incorporating public comments and establishing clear communication channels.

Primary source: Advisory Committee Guidance Documents

PV Impact Brief

Urgency: HighConfidence: high

What changed

FDA finalized a guidance document detailing formal meeting protocols between FDA and sponsors of OTC monograph drugs, outlining meeting types, submission requirements, and procedures for engagement.

Why it matters

This guidance provides clarity on communication pathways and procedural expectations for sponsors, enhancing regulatory predictability and compliance in discussions involving safety signals and other regulatory topics.

Action needed

Sponsors must adhere to defined meeting types (Type X, Y, Z) and submit meeting packages at least 3 months before planned submissions for OTC monograph drugs, ensuring FDA engagement occurs within set timelines.

Relevant for
Regulatory Intelligence LeadQPPV
Processes impacted
Country Compliance
Owner

Regulatory Intelligence Lead

Review cadence

As needed

Policy change details

Document type
Guideline
Policy status
final
Publication date
2026-07-13
Policy change
FDA issued a final guidance providing recommendations for formal meetings between FDA and sponsors/requestors of OTC monograph drugs, as required by the CARES Act.

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 It finalizes the draft guidance issued in February 2022 and incorporates changes based on public comments, including those related to meeting requests and the use of written responses.

Affected workflows

Country Compliance

Responsible groups

Regulatory AffairsPharmacovigilance Operations

Document identifiers

FDA-2022-D-0080

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.

View regulator source

Source document details

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

Country ComplianceRegulatory Affairs

Requires adherence to the meeting types and submission timings

Establishes defined procedures for formal meetings

The guidance specifies meeting types and associated procedures · p. 7 · High · Source

Extracted documents

Evidence and confidence

Confidence: highSource updated: Jul 13, 2026

Full briefing

Practical implication

Sponsors must adhere to defined meeting types (Type X, Y, Z) and submit meeting packages at least 3 months before planned submissions for OTC monograph drugs, ensuring FDA engagement occurs within set timelines.

The FDA's new guidance outlines the procedures for conducting formal meetings with sponsors of over-the-counter (OTC) monograph drugs, as required by the CARES Act. It finalizes earlier draft guidance and establishes types of meetings, submission timings, and user fee program information.

What changed: FDA finalized a guidance document detailing formal meeting protocols between FDA and sponsors of OTC monograph drugs, outlining meeting types, submission requirements, and procedures for engagement.

Why it matters: This guidance provides clarity on communication pathways and procedural expectations for sponsors, enhancing regulatory predictability and compliance in discussions involving safety signals and other regulatory topics.

Practical implication: Sponsors must adhere to defined meeting types (Type X, Y, Z) and submit meeting packages at least 3 months before planned submissions for OTC monograph drugs, ensuring FDA engagement occurs within set timelines.

View original source

Published from the Firecrawl policy change extraction pipeline.

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