From DCAT Value Chain Insights (VCI)
The US Food and Drug Administration (FDA) has issued draft guidance, Formal Dispute Resolution: Appeals Above the Division Level Guidance for Industry and Review Staff. The guidance provides recommendations for industry and review staff on the procedures in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for resolving scientific and/or medical disputes that cannot be resolved at the division level. This guidance describes the formal dispute resolution (FDR) procedures for formally appealing scientific and/or medical issues to the office or center level and provides a structured procedure for resolving disputes.
During the course of review of an investigational new drug application (IND), new drug application (NDA), biologics license application (BLA), or abbreviated new drug application (ANDA), a wide variety of important scientific and/or medical issues are discussed that are central to product development. Sometimes, a sponsor may disagree with the FDA on a matter, and a dispute arises. Because these disputes often involve complex scientific and/or
medical matters, the draft guidance outlines to procedures to help ensure open, prompt discussion. The procedures and policies described in the guidance are intended to promote rapid resolution of scientific and/or medical disputes between sponsors and CDER or CBER.
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