The FDA issued draft guidance for industry titled “Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug and Cosmetic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The draft guidance provides recommendations on the formal dispute and administrative hearing procedures with respect to final orders under section 505G of the Food, Drug and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 This draft guidance also outlines the procedures for an administrative hearing related to a final order.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FDA committed to issuing a draft guidance on consolidated proceedings and updating the existing CDER FDR guidance, CDER Formal Dispute Resolution: Sponsor Appeals Above the Division Level (Nov. 2017).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for final orders and issuing a separate guidance for consolidated proceedings for appeals, FDA is issuing this single draft guidance.
Comments regarding this draft guidance should be submitted following the information in the notice of availability that will be posted in the Federal Register shortly. More information regarding OTC Monograph Reform is available on FDA’s OTC Monograph Reform webpage and at OTC Monographs @ FDA.
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