| November 6, 2009 | News for the biotech, medical device, drug and food regulatory profession |
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| Drugs & Biologics |  |  |
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- Trial sites to be fined if they don't disclose privacy breaches
A provision in the American Recovery and Reinvestment Act of 2009 requires clinical-trial facilities to disclose privacy breaches to patients. Those breaking the rule could pay a fine of as much as $50,000 per violation, with penalties slated to be enforced starting Feb. 23. Affected individuals must be notified of the breach within 60 days of discovery, according to the policy. HealthImaging.com
(11/6)
 
- CDC urges officials to review distribution of H1N1 vaccine
The CDC notified state and major city health departments to prioritize vaccinating pregnant women, children and other groups at high risk of H1N1 influenza, after government officials were criticized for distributing the vaccine to some Wall Street companies. "Any vaccine-distribution decisions that appear to direct vaccine to people outside the identified priority groups have the potential to undermine the credibility of the program," CDC Director Thomas Frieden said. The Wall Street Journal
(11/6)
- South Korean drug regulator probes Roche over Tamiflu stockpiling
The Korea Food and Drug Administration launched an investigation into allegations that Roche Holding illegally helped multinational companies, including South Korean units of Novartis and HSBC, buy large batches of flu drug Tamiflu amid a surge in the number of H1N1 flu cases in the country. A spokeswoman for Roche said the company is "fully collaborating with the authorities." Bloomberg
(11/6)
| Health Care in Transition | | |
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- House Democrats seek 218 votes to pass health care bill
As a likely weekend vote on a sweeping overhaul of the U.S. health care system draws closer, House Democratic leaders intensified their efforts to line up the 218 votes they need to pass the measure. Party leaders said they didn't have enough confirmed votes to guarantee passage but were confident of having them by the time the bill comes to the floor of the House of Representatives, probably Saturday. The New York Times
(11/5)
, The Washington Post
(11/6)
| Biotechnology | | |
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- Researchers tout success of gene therapy in 2 ALD patients
French researchers were able to stabilize adrenoleukodystrophy, a degenerative condition, in two boys by inserting a healthy form of the ALD gene into debilitated HIV and introducing it to isolated bone marrow cells. The team plans to perform the procedure in other groups, including older men with a milder form of the disease. Los Angeles Times
(11/6)
| Food & Dietary Ingredients | | |
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| Medical Devices | | |
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- FDA issues reminder to clarify cybersecurity issues
The FDA issued a notice saying it does not regulate changes to medical device software developed for cybersecurity purposes. The agency also advised device firms to be responsible when it comes to addressing computer viruses and other cybersecurity threats, as well as collaborate with hospitals and clinics to solve such issues. Clinica (subscription required)
(11/5)
- W.L. Gore seeks approval of bonds to fund expansion in Phoenix
W.L. Gore & Associates will ask the city of Phoenix to approve bonds worth up to $30 million to help fund a $100 million project as part of its expansion in the city. The expansion plan includes the establishment of two manufacturing facilities and is expected to generate 500 permanent jobs. The progress of the expansion will be influenced by the firm's growth and approval of devices for cardiovascular diseases and other treatment areas, said the company's corporate counsel. The Arizona Republic (Phoenix)
(11/5)
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Speakers are confirmed for the Nov. 10 Tobacco Product Regulation conference!
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Written and edited by the most experienced food and drug attorneys in the U.S., Food and Drug Law and Regulation is the definitive resource on food and drug law. Chapters include penetrating analysis and current legal citations that will expedite your legal research. Purchase online. Purchase by fax.
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