FDA Dispute Resolution Process Invoked About 10 Times Annually
This article was originally published in The Pink Sheet Daily
Executive Summary
CDER handles about nine dispute resolution requests per year on average, and CBER only one.
You may also be interested in...
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.
Bydureon Review Documents Paint An Unflattering Portrait Of Amylin
Division of Metabolism and Endocrinology Products Director Mary Parks said the review of exenatide extended-release was delayed and complicated by the company’s withholding of important information about the QT effects of Byetta, an assertion the sponsor disputes. Amylin’s appeal of a second “complete response” letter failed to overturn the requirement for a new QT study pre-approval.
Small Companies Turning To CDER Ombudsman For Help With Drug Approvals
While the CDER ombudsman dealt with far fewer complaints overall in 2011 than in 2010 due to administrative changes, smaller companies are increasingly asking for help in certain key areas of drug development.