Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act

Issue Date: December 22, 2025
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural
Status: Final

Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act

The Food and Drug Administration (FDA or Agency) is 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 for industry and review staff on the formal dispute resolution (FDR) and administrative hearings procedures for resolving scientific and/or medical 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) (“Final Order”). This guidance finalizes the draft guidance of the same title issued on June 23, 2023.

Download the Guidance Document