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USFDA Guidance: Formal Dispute Resolution and Administrative Hearings for OTC Monograph Drugs

Today (22 June 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research released a draft guidance on "Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders".

Formal dispute resolution (FDR) is a structured process designed to address and resolve conflicts or disputes between parties in a formal, systematic manner. It is often used when there is a disagreement or controversy that cannot be resolved through informal means.


This guidance provides recommendations for resolving scientific and/or medical disputes between CDER and requestors and sponsors of over-the-counter (OTC) monograph drugs who will be subject to final orders under 505G of the FD&C Act, including formal dispute resolution (FDR).


Moreover, this draft guidance covers the procedures for an administrative hearing related to a final order, as well as those for consolidated proceedings for the FDR and hearings to resolve scientific and/or medical disputes.


To determine what steps need to be taken to resolve the scientific and/or medical dispute, a request for FDR should include sufficient information to explain the nature of the dispute.


Upon completion of FDR up to the Director of CDER, FDA will inform the eligible requestors and sponsors that participated in each stage of FDR of their right to request a hearing.


Click this LINK to know in depth about the Content and Format of a Request for FDR, etc.

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