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 chief to step down [1]
- Diabetes drugs face higher hurdle at FDA [2]
- Sharfstein looks to be on FDA short list [3]
- Survey says: Nissen or Rost for Commish [4]
- Sweep the FDA clean, Stupak says [5]
FDA reform doesn't top Obama's list [6]
- FDA advisers skeptical of retrospective genetic analysis [7]
- FDA adopts simulation tech [8]
FDA Decisions
- FDA: Pancreatic enzyme necessary [9]
- FDA panel votes down two asthma meds [10]
- FDA rejects Salix's ulcerative colitis drug [11]
- AMAG shares slump on new FDA letter [12]
- Pain shares tumble as FDA asks for Remoxy data [13]
- FDA: Targanta must conduct new study [14]
- Roche hit with major Actemra delay [15]
- Slow-moving FDA misses deadline [16]
FDA Approvals
- FDA approvals up, missed deadlines abound [17]
- FDA approves Degarelix [18]
- Epix shares soar on Vasovist approval [19]
- Genzyme, Abbott score FDA approvals [20]
- Abbott's TriCor follow-up gets FDA nod [21]
- FDA approves Allergan's eyelash drug [22]
Safety, Warnings and Recalls
- Anti-Epileptic meds issued FDA warning [23]
- FDA mandates warnings for epilepsy meds [24]
- Asthma meds draw FDA scrutiny [25]
Who's afraid of the adverse event? [26]
- Did AstraZeneca ignore Seroquel risk data? [27]
Links:
[1] http://www.fiercepharma.com/story/fda-chief-step-down-obamas-sworn/2008-12-16
[2] http://www.fiercebiotech.com/story/diabetes-drug-developers-face-higher-hurdle-fda/2008-12-18
[3] http://www.fiercepharma.com/story/sharfstein-looks-be-fda-short-list/2008-12-12
[4] http://www.fiercepharma.com/story/survey-says-nissen-or-rost-fda-commish/2008-12-19
[5] http://www.fiercepharma.com/story/sweep-fda-clean-stupak-says/2008-12-05
[6] http://www.fiercepharma.com/story/fda-reform-doesnt-top-obamas-list/2008-12-22
[7] http://www.fiercebiotech.com/story/fda-advisers-skeptical-retrospective-genetic-analysis/2008-12-17
[8] http://www.fiercebiotech.com/story/fda-adopts-simulation-tech/2008-12-16
[9] http://www.fiercepharma.com/story/fda-calls-pancreatic-enzyme-medically-necessary/2008-12-03
[10] http://www.fiercepharma.com/story/fda-panel-votes-down-two-asthma-meds/2008-12-12
[11] http://www.fiercebiotech.com/story/fda-rejects-salixs-ulcerative-colitis-drug/2008-12-30
[12] http://www.fiercebiotech.com/story/amag-shares-slump-new-fda-letter/2008-12-23
[13] http://www.fiercebiotech.com/story/pain-shares-tumble-fda-asks-more-remoxy-data/2008-12-11
[14] http://www.fiercebiotech.com/story/fda-targanta-must-conduct-new-oritavancin-study/2008-12-09
[15] http://www.fiercebiotech.com/story/roche-hit-major-delay-actemra-approval/2008-12-04
[16] http://www.fiercebiotech.com/story/slow-moving-fda-misses-deadline-takeda-drug/2008-12-24
[17] http://www.fiercebiotech.com/story/fda-approvals-jump-08-missed-deadlines-abound/2008-12-22
[18] http://www.fiercebiotech.com/story/fda-approves-prostate-cancer-drug-degarelix/2008-12-30
[19] http://www.fiercebiotech.com/story/epix-shares-soar-vasovist-approval/2008-12-23
[20] http://www.fiercebiotech.com/story/genzyme-abbott-score-fda-approvals-new-drugs/2008-12-16
[21] http://www.fiercepharma.com/story/abbotts-tricor-follow-gets-fda-nod/2008-12-16
[22] http://www.fiercepharma.com/story/fda-approves-allergans-eyelash-growth-drug/2008-12-27
[23] http://www.fiercebiotech.com/pages/anti-epileptic-meds-issued-fda-suicide-risk-warning
[24] http://www.fiercepharma.com/story/fda-mandates-suicide-warnings-antiepileptic-medications/2008-12-17
[25] http://www.fiercepharma.com/story/asthma-meds-draw-fda-scrutiny/2008-12-05
[26] http://www.fiercepharma.com/story/whos-afraid-adverse-event/2008-12-09
[27] http://www.fiercepharma.com/story/did-astrazeneca-ignore-seroquel-risk-data/2008-12-05
