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# Guide on OTC Monograph Dispute Resolution
- URL: https://www.fdaweb.com/guide-on-otc-monograph-dispute-resolution/
- Published: 2023-06-23T12:00:00.000Z
- Updated: 2026-09-14T18:40:46.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154757

*Federal Register* notice: FDA is making available a draft guidance entitled “Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act.” The document provides recommendations on the formal dispute resolution and administrative hearings procedures for resolving scientific and medical disputes between CDER and drug sponsors that will be subject to a final administrative order (final order) under section 505G of the Federal Food, Drug, and Cosmetic Act (over-the-counter monograph drugs). It also outlines the procedures for an administrative hearing related to a final order. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-06-23/pdf/2023-13331.pdf?ref=fdaweb.com).