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.
You may also be interested in...
Agency makes clear that triglyceride levels are no longer an acceptable surrogate for reducing cardiovascular risk.
The agency was expecting many pending generic drug submissions to be withdrawn because sponsors would not want to pay the one-time backlog fee, but instead saw a substantial increase near the end of FY 2012.
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.