Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act December 2025

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-dispute-resolution-and-administrative-hearings-final-administrative-orders-under-section-505g?utm_medium=email&utm_source=govdelivery FDA Issues Final Guidance About Formal Dispute and Administrative Hearings of Final Orders for OTC Monograph Drugs Today, the U.S. Food and Drug Administration issued a final guidance for industry titled “Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug and Cosmetic Act.” The guidance provides recommendations on the formal dispute and administrative hearing procedures with respect to final orders under section 505G of the Food, Drug and Cosmetic Act (FD&C Act). It provides recommendations on the procedures, including formal dispute resolution (FDR), for resolving scientific and/or medical disputes between CDER and requestors and sponsors of over-the-counter (OTC) monograph drugs that will be subject to a final order under section 505G of the FD&C Act. This guidance also outlines the procedures for an administrative hearing related to a final order. Finally, it describes the procedures for consolidated proceedings for FDR and hearings to resolve the scientific and/or medical disputes. FDA committed to issuing a guidance on consolidated proceedings and updating the existing CDER FDR guidance, CDER Formal Dispute Resolution: Sponsor Appeals Above the Division Level (Nov. 2017). For efficiency, rather than amending FDA’s existing FDR guidance to include FDR procedures for final orders and issuing a separate guidance for consolidated proceedings for appeals, FDA is issuing this single draft guidance.