Formal Dispute Resolution: Sponsor Appeals Above the Division Level Guidance for Industry and Review Staff

Issue Date: May 30, 2019
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural
Status: Final

Formal Dispute Resolution: Sponsor Appeals Above the Division Level Guidance for Industry and Review Staff

This 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 between CDER or CBER and sponsors that cannot be resolved at the division level. This guidance describes the formal dispute resolution (FDR) procedures for sponsors that wish to appeal a scientific and/or medical issue to the office or center level and provides a structured process for resolving disputes.

Download the Guidance Document

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