Small Companies Turning To CDER Ombudsman For Help With Drug Approvals
This article was originally published in The Pink Sheet Daily
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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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.
CDER handles about nine dispute resolution requests per year on average, and CBER only one.