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    Demystifying the FDA Appeals Process

    For more than a decade, there has been confusion about the appeals process at the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). There are several avenues to file an appeal, each with specific requirements. This article aims to clarify the CDRH appeals process so stakeholders can use it effectively. The relevant processes for FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research ...