Welcome 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.
Links:
[1] http://www.fiercepharma.com/story/fda-considers-toll-free-numbers-dtc-ads/2008-11-26
[2] http://www.fiercepharma.com/story/fda-goes-china/2008-11-19
[3] http://www.fiercepharma.com/story/should-kessler-return-fda/2008-11-10
[4] http://www.fiercepharma.com/story/wholl-take-over-fda-and-hhs/2008-11-06
[5] http://www.fiercepharma.com/story/kindler-take-politics-out-fda/2008-11-03
[6] http://www.fiercepharma.com/story/fda-examine-cv-side-effects-several-meds/2008-11-19
[7] http://www.fiercepharma.com/story/fda-persecuting-indias-generics-makers/2008-11-17
[8] http://www.fiercepharma.com/story/fake-fda-special-agents-work-drug-scam/2008-11-13
[9] http://www.fiercepharma.com/story/fda-seizes-tainted-celsus-heparin/2008-11-07
[10] http://www.fiercepharma.com/story/can-fda-ever-safeguard-china-made-meds/2008-11-03
[11] http://www.fiercepharma.com/story/fda-calls-all-clear-bone-meds/2008-11-13
[12] http://www.fiercebiotech.com/story/basilea-shares-plunge-major-delay-antibiotic/2008-11-26
[13] http://www.fiercebiotech.com/story/fda-panel-votes-theravance-antibiotic-rejects-targanta-bid/2008-11-20
[14] http://www.fiercebiotech.com/story/fda-embeda-could-carry-abuse-risk/2008-11-13
[15] http://www.fiercebiotech.com/story/2008-nme-approvals-will-surpass-2007/2008-11-21
[16] http://www.fiercebiotech.com/story/promacta-gets-fda-approval/2008-11-21
[17] http://www.fiercebiotech.com/story/fda-committee-backs-first-new-gout-drug-40-years/2008-11-25
[18] http://www.fiercebiotech.com/story/fda-announces-several-approvals/2008-11-03