| December 3, 2008 | News for the biotech, medical device, drug and food regulatory profession |
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| Drugs & Biologics |  |  |
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- Expert: Faster approvals, aggressive ads may risk safety
Fresh approaches in selling medicines as well as policy changes to expedite approval may compromise drug and patient safety, a researcher at the University of Colorado Health Sciences Center reported. However, multimedia promotional techniques also could be applied in postmarketing surveillance of treatments to help improve safety oversight, Dr. David Kao said. Reuters
(12/3)  
- Cleveland Clinic set to post staff's financial links to firms
The Cleveland Clinic is poised to announce that its Web site contains information detailing its staff's financial relationships with drug and medical-device companies. The center requires its researchers and doctors to disclose industry dealings at least once a year as well as to notify editors of medical journals about such ties. NYTimes.com
(12/2)
| Biotechnology | | |
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- Stem cell surgery could benefit heart patients
U.K. researchers are working on a technique to repair damaged hearts using progenitor cells derived from patients' own cardiac muscle. The method could help eliminate the need for transplants and decrease the number of deaths caused by heart attacks. The scientists have successfully tested the treatment on mice and hope to conduct human studies within three years. Telegraph (London)
(12/3)
- Stroke patient responds well to stem cell therapy
A 49-year-old man who received Biocompatibles International's stem cell therapy for stroke regained speech and recovered from paralysis, CEO Crispin Simon said. Simon clarified that the findings were from a single case and not outcomes from a study of the treatment, which is in Phase I/II development. Reuters
(12/2), The Times (London) (subscription required)
(12/3)
| Food & Dietary Ingredients | | |
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- In Kansas, a battle over rBST labels
Anti-biotech forces are fighting a proposed Kansas law that would ban dairy product labels from stating the product is "rBST free." The rule also calls for disclaimers saying "the FDA has determined that no significant difference has been shown between milk derived from rBST-supplemented and non-rBST-supplemented cows." Reuters
(12/2)
| Medical Devices | | |
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- Research finds increase in lifetime cancer risk from CT scans
A U.S. study found that the lifetime risk of cancer slightly increased in as many as 7% of patients who have been routinely exposed to radiation from CT scans. The study is part of an effort to develop tools that would help doctors evaluate the overall cancer risk of patients based on their history of CT scans. Yahoo!/Reuters
(12/2)
| FDLI Items | | |
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What can the food industry expect from FDA during the new administration?
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