FDA Finalizes Guidance on Drug Dispute Resolution

Detected February 6th, 2026

Summary

The FDA has finalized guidance for industry on formal dispute resolution and administrative hearings for drugs subject to final administrative orders under section 505G of the FD&C Act. This guidance provides recommendations for resolving scientific and medical disputes between the Center for Drug Evaluation and Research (CDER) and drug sponsors.

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The FDA has issued final guidance for industry titled "Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act." This document, associated with Docket Number FDA-2023-D-2204, provides recommendations for both industry and FDA review staff concerning procedures for resolving scientific and/or medical disputes that arise between the Center for Drug Evaluation and Research (CDER) and sponsors of drugs subject to a final administrative order under section 505G of the FD&C Act. This final guidance supersedes the draft guidance of the same title issued on June 23, 2023.

This guidance is non-binding and offers recommendations for navigating dispute resolution processes. While comments can be submitted at any time, the primary impact is on drug manufacturers and sponsors who may engage with CDER regarding scientific or medical disagreements related to final administrative orders. The guidance aims to clarify procedures and ensure consistent application of dispute resolution mechanisms within the drug approval and post-approval processes.

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Docket Number: FDA-2023-D-2204 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research 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.