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GUIDANCE DOCUMENT

Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act June 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

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

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 Center for Drug Evaluation and Research (CDER) and requestors and sponsors of drugs that will be subject to a final administrative order (final order) under section 505G of the Food, Drug, and Cosmetic Act (FD&C Act)(21 U.S.C. 355h). The drugs that this guidance covers are nonprescription drugs without approved new drug applications, which are governed by the provisions of section 505G (hereafter referred to as over-the-counter (OTC) monograph drugs Specifically, this guidance describes the CDER formal dispute resolution (FDR) procedures for eligible requestors or sponsors that wish to appeal a scientific and/or medical issue related to a final order. This guidance also outlines the procedures for an administrative hearing (hearing) related to a final order. Finally, this guidance describes the procedures for consolidated proceedings for FDR and hearings to resolve scientific and/or medical disputes related to final orders.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-2204.

 
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