On December 23, 2025, the Food and Drug Administration (FDA) published a Federal Registerthe notice announcing the availability of a final guidance for industry entitled "Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act."
This guidance provides recommendations on the formal dispute resolution (FDR) and administrative hearings procedures for resolving disputes between the Center for Drug Evaluation and Research (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 (FD&C Act).
Background
Section 505G of the FD&C Act was added by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) in March 2020. After the FDA issues a Final Order in accordance with section 505G(b)(2) of the FD&C Act, the FDA must afford eligible requestors or sponsors the opportunity for FDR and hearings on disputes over the Final Order.
The FDA previously agreed to specific performance goals and procedures described in a commitment letter (read here). The commitment letter specified that the agency would revise previous guidance for industry to include circumstances and procedures under which FDR may be used with respect to Final Orders under section 505G of the FD&C Act. The letter also stated that the agency would issue guidance on its views regarding best practices for consolidated proceedings for appeals.
Rather than amend the existing FDR guidance to include FDR procedures for Final Orders and issue a separate guidance for consolidated proceedings for appeals, the FDA is issuing this single guidance to address both issues.
This guidance finalizes the earlier draft guidance published in June 2023. The FDA considered comments received on that draft during its guidance finalization process.
Updated Guidance
This guidance provides recommendations for industry and review staff on the formal dispute resolution and administrative hearings procedures for resolving scientific and/or medical disputes between the CDER and requestors and sponsors of drugs that will be subject to a final administrative order under section 505G of the FD&C Act.
The drugs that this guidance covers are nonprescription drugs without approved new drug applications, which are subject to section 505G.
The guidance addresses:
- CDER's FDR procedures for eligible requestors or sponsors that wish to appeal a scientific and/or medical issue related to a Final Order.
- The procedures for an administrative hearing related to a Final Order.
- The procedures for consolidated proceedings for FDR and hearings to resolve scientific and/or medical disputes related to Final Orders.
Reminder: FDA's guidance documents do not establish legally enforceable responsibilities. Guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
Affected parties can submit online or written comments on any guidance at any time.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
