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.

Amid a massive general decline in the number of initial queries filed with the FDA Center for Drug Evaluation and Research Ombudsman, the number of industry queries is on the rise, driven by small companies’ need for help navigating the drug approval process, according to the ombudsman’s annual report.

Notably, 69% of the 153 initial contacts from industry, consultants, media, whistleblowers, law firms and research sponsors came from commercial...

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