November FDA news in review

fda.sp.pngWelcome to the November installment of "FDA News in Review," where each month we look at the agency's latest decision, approvals, warnings and recalls. With a new president on his way to the office, there was a lot of speculation in November about who would take over the FDA after Andrew von Eschenbach leaves. Senator Tom Daschle has already been nominated to run HHS and Rep. Henry Waxman will take over the House Energy and Commerce Committee, which oversees the FDA and the drug and device industries. A number of names have been bandied about for the Comissioner spot, including Janet Woodcock (an industry favorite) and Steve Nissen (the industry's worst-case nominee).

November was also a big month for FDA approvals, with the agency evaluating a slate of new antibiotics and granting approval to the first new gout drug in 40 years. The blog In Vivo crunched the numbers and found that 2008 is shaping up to be a better new drug approval year than 2007, when only 18 NMEs were approved. The FDA has already approved 18 NMEs, and ten more drug applications could be approved before the end of the year.

What's New at the FDA

  • FDA considers toll-free numbers
  • FDA goes to China
  • Should Kessler return to the FDA?
  • Who will take over at the FDA, HHS?
  • Kindler: Take politics out of the FDA

Safety, Warnings and Recalls

  • FDA to examine CV side effects of meds
  • Is the FDA after India's generics makers?
  • Fake FDA 'special agents' work drug scam
  • FDA seizes tainted Celsus heparin
  • Can FDA safeguard China-made meds?


FDA Decisions

  • FDA calls 'all clear' on bone meds
  • Basilea plunges on major delay for antibiotic
  • FDA backs Theravance antibiotic
  • FDA: Embeda could carry abuse risk

FDA Approvals

  • 2008 NME approvals will surpass 2007
  • Promacta gets FDA approval
  • FDA panel backs first new gout drug in 40 years
  • FDA announces several approvals


November FDA news in review
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