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.
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Appeals pathway remains unavailable for challenging regulatory advice on drug and biologic product development programs despite objections from industry; sponsors may approach a higher management level to further discuss such advice in meetings established under the user fee programs, final guidance states.
Sponsor hopes to demonstrate that FDA's process for reviewing extended-release abuse-deterrent opioids may not be appropriate for an immediate-release product. Apadaz would be the first immediate-release opioid with an abuse-deterrent claim if approved.
Sponsors should think about more than just a single efficacy data point when assembling their designation requests because the agency looks at the ‘entire puzzle’ in deciding whether ‘breakthrough’ status is warranted.