Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
Health and Human Services Department, Food and Drug Administration
Questions this answers
Sources
- Federal Register · checked 2025-12-23
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The underlying regulation record — supporting evidence for the object above.
Key Details
- Posted Date
- Source
- Federal Register
Description
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 This guidance finalizes the draft guidance of the same title issued on June 23, 2023.