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Small Companies Turning To CDER Ombudsman For Help With Drug Approvals

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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FDA Sponsor Liaison Program Is Not Being Used: Are Small Biotechs Missing An Opportunity? Or Partnering More?

FDA has noticed a perplexing – and somewhat vexing – trend among smaller, less experienced pharma companies: They are not taking full advantage of a new liaison program designed to increase sponsor/FDA communication – even when they hit roadblocks during the drug review process. FDA officials have heralded the program as one of the most important under PDUFA V. So why aren’t companies using it?

Calling The Ombudsman: Contacts With ANDA Sponsors, Investors On The Upswing

Although the number of contacts from commercial sponsors and the pharmaceutical industry held steady in 2012, the CDER ombudsman’s office heard from more generic drug manufacturers and investors than in the prior year.

FDA Dispute Resolution Process Invoked About 10 Times Annually

CDER handles about nine dispute resolution requests per year on average, and CBER only one.

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