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# Formal Dispute Resolution Guidance
- URL: https://www.fdaweb.com/formal-dispute-resolution-guidance/
- Published: 2026-01-06T12:00:00.000Z
- Updated: 2026-09-14T15:29:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160435

FDA has published a guidance, *Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act*, with recommendations on the formal dispute resolution and administrative hearing procedures for resolving scientific and/or medical disputes between CDER and requestors and sponsors of drugs that will be subject to a final administrative order under section 505G of the Federal Food, Drug, and Cosmetic Act. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-dispute-resolution-and-administrative-hearings-final-administrative-orders-under-section-505g?ref=fdaweb.com) says it covers nonprescription drugs without approved NDAs that are governed by provisions of section 505G (over-the-counter monograph drugs).

The guidance contains an Introduction, Background, Formal Dispute Resolution, Administrative Hearing, and Consolidated Proceedings.