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April 23, 2012News for the biotech, medical device, drug and food regulatory profession

  Drugs & Biologics 
  • FDA defends post-approval monitoring of drugs
    Since 2008, the FDA has monitored drugs on the market by ordering 385 post-market studies and 65 label changes, the regulator said in a report. The report is in response to criticism that the agency is not as stringent in tracking the safety of approved drugs as it is when it considers whether to approve treatments. Reuters (4/21) Email this Story
  • Pfizer must pay woman at least $4 million in Prempro case
    A federal jury ruled that Pfizer should pay Margaret Fraser, a woman who developed breast cancer after taking menopause drug Prempro, no less than $4 million in damages. "We are disappointed with the verdict and will evaluate our legal options once the court completes its work in this case," company spokesman Chris Loder said. Bloomberg (4/20) Email this Story
  Global Focus 
  • EU regulator proposes heart warning for Gilenya's safety label
    The European Medicines Agency's Committee for Medicinal Products for Human Use proposed to include a cardiovascular warning for Gilenya, Novartis' drug for multiple sclerosis. The committee suggested that the firm encourage patients to have their heart rhythm, blood pressure and ECG checked before taking the drug and undergo close monitoring after starting treatment. MedPage Today (free registration) (4/21), Bloomberg (4/20) Email this Story
  Food & Dietary Supplements 
  • FDA, OMB work to release key FMSA rules months after deadline
    The FDA is under pressure from consumer and food safety groups to implement rules mandated by Congress under the Food Safety Modernization Act, which the agency was supposed to have finished by January. The White House Office of Management of Budget's Office of Information and Regulatory Affairs is reviewing rules that cover produce safety, foreign supplier verification and the preventive controls for food facilities. "Not only is each complicated ... they're interconnected. This is why they're traveling as a package," said Michael Taylor, the FDA's deputy commissioner for foods. (4/23) Email this Story
  Featured Content 
Most Popular Headlines from Last Week
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  Medical Devices 
  • Carestream's mobile X-ray system lands FDA clearance
    The FDA has given Carestream Health clearance to market its DRX-Revolution system among health care facilities in the U.S. The company said the mobile X-ray device comes with a DRX detector, 32-kilowatt generator and software that allows the tube to be aligned with a grid. (4/19) Email this Story
  • FDA clears 3D foot and ankle scanner from CurveBeam
    CurveBeam has obtained 510(k) clearance from the FDA for its pedCAT 3D scanner, which employs cone-beam CT technology to generate ankle and foot images under weight-bearing conditions. The device gives doctors a more detailed and accurate look at foot conditions, allowing them to improve treatment planning and better predict surgical results. (4/20) Email this Story
  Hot Topics 

Top five news stories selected by FDLI SmartBrief readers in the past week.

  • Results based on number of times each story was clicked by readers.
  FDLI Items 
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Junior to Mid-Level FDA & Healthcare AssociateMorgan LewisWashington, DC
AttorneyDept. of Health and Human Services, FDA, Office of the Chief CounselSilver Spring, MD
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Corporate Counsel/Senior Corporate CounselGenentechSouth San Francisco, CA
CounselVerto Solutions, LLCWashington DC, DC
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