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.
Dispute Resolution Strategies: FDA Clarifies Which Issues Can Be Appealed
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.