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Dispute Resolution Strategies: FDA Clarifies Which Issues Can Be Appealed

 
• By Sue Sutter

Matters ripe for appeal above review division level include denial of request for breakthrough therapy designation, revised guidance states, but general advice – such as how to conduct a clinical research program – are not appealable.

FDA's clarification of the types of issues for which product sponsors may seek formal dispute resolution likely will serve to limit how often preliminary problems move up the chain of command within its drug and biologic product centers.

A revised draft guidance, "Formal Dispute Resolution: Appeals Above the Division Level," addresses the steps sponsors should take if they wish to formally appeal a scientific or medical...

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More from North America

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