January FDA news in review


Frank Torti was named acting commissioner of the FDA, ending months of speculation about who would take the top FDA post in the Obama Administration. Torti was formerly the FDA's chief scientist and principal deputy commissioner, and before that worked as a cancer researcher and director of the Comprehensive Cancer Center of Wake Forest University. He will serve as the FDA's head until a permanent leader is named (Duke cardiologist Robert Califf and Baltimore Health Commissioner Joshua Sharfstein have been mentioned), or until Torti himself is handed the job for good.

In other big FDA news, the agency approved the first human trial of a therapy derived from embryonic stem cells. Geron will inject paraplegic subjects with a single stem cell injection in the spine and monitor the Phase I trial for safety. Stem cell advocates celebrated the approval as the first step toward studying a technology that could offer real medical breakthroughs in the coming years. ESC research has been hampered in the U.S. due to lack of federal funding, though those restrictions will be lifted under the Obama Administration.

What's new at the FDA

  • FDA scientist Torti moves to the helm
  • FDA opens doors in Costa Rica
  • Ex-FDA chief Henney could return
  • FDA launches drug safety pilot program
  • GAO: FDA's device review too slack
  • Report outlines FDA disregard for trial conflicts

FDA Delays

  • Lilly's Zyprexa shot faces FDA delay
  • KV Pharma suspends operations, delays Gestiva
  • FDA wants more data on Schering's Saphris
  • FDA delays Gardasil for older women
  • FDA wants more info on Pfizer's Fablyn
  • FDA approves new fibromyalgia drug

FDA Decisions

  • FDA approves new fibromyalgia drug
  • FDA's green light for stem cell trial thrills scientists
  • FDA committee backs Lilly's prasugrel

Safety, Warnings and Recalls

  • FDA: Asthma drugs, suicidiality not linked
  • Vytorin gets boost after FDA data review
  • FDA puts Plavix under safety review
  • FDA experts to consider Darvon ban

January FDA news in review

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