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Small Companies Turning To CDER Ombudsman For Help With Drug Approvals

 
• By Martin Berman-Gorvine

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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• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

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