December FDA news in review
With inauguration day fast approaching, December was all about what's next at the FDA. Commissioner Andrew von Eschenbach officially announced that he will step down on January 20th when President-elect Obama takes office. His successor is yet to be named and, of course, speculation has soared over who will be elected to the FDA's top spot. CDER chief Janet Woodcock, Cleveland Clinic cardiologist Steve Nissen, former Pfizer-ite Peter Rost and Baltimore Health Department chief Joshua Sharfstein are all reported to be on the short list for the spot.
Meanwhile, the agency was quite busy approving (and rejecting) new therapies. The FDA approved 24 novel therapies in 2008, up from a paltry 18 in 2007. But it also missed a number of PDUFA deadlines--the agency's part of the deal it made in exchange for the industry's financial support. It's unlikely that 2009 will bring a major boost in funding, which means drug developers will continue to wait for guidance and decisions from the agency.
What's new at the FDA
FDA Decisions
- FDA: Pancreatic enzyme necessary
- FDA panel votes down two asthma meds
- FDA rejects Salix's ulcerative colitis drug
- AMAG shares slump on new FDA letter
- Pain shares tumble as FDA asks for Remoxy data
- FDA: Targanta must conduct new study
- Roche hit with major Actemra delay
- Slow-moving FDA misses deadline
FDA Approvals
Safety, Warnings and Recalls
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