Dispute Resolution Strategies: FDA Clarifies Which Issues Can Be Appealed
Executive Summary
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.
You may also be interested in...
In US OTC Monograph Program, ‘FDR’ Spells Appealing FDA's Rejections Of Change Requests
Draft guidance adds “formal dispute resolution” to other terms becoming common in OTC drug sector since agency began overhaul of monograph drug program authorized in 2020. Others are OMOR, for OTC monograph order request, and OMUFA, for user fee program also authorized.
US FDA To Sponsors: No Dice On Appealing Advice Through Dispute Resolution
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.
KemPharm Seeks FDA Dispute Resolution Over Apadaz's Abuse Deterrence
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.