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Drug and Medical Device Safety

Medical Devices 



Recent Blog Posts



View Post: Not Suitable for Medical Use — Electrical Safety Testing Under ...
13 hours ago by Greg Smith  
The proposed H.R. 1346: Medical Device Safety Act of 2009 would amend the Federal Food, Drug and Cosmetic Act to provide legal recourse to patients who are injured by a medical device that malfunctions. 9 ...
View Blog: IAEI Magazine Online - http://www.iaei.org/magazine/



View Post: Under the Radar Healthcare Stocks: Protox, Pressure BioSciences ...
24 Nov 2009 by Mike Havrilla  
More than two billion prefilled syringes are currently used each year on a global basis and pharmaceutical companies are making the switch to products such as Unilife's safety syringe which are compliant with needle-stick prevention laws ... The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); ...
View Blog: BioMedReports.Com - http://biomedreports.com/



View Post: Correcting Injustice--The Medical Device Safety Act
InjuryBoard ...
26 Oct 2009 by John Hopkins   ...
View Blog: http://www.injuryboard.com/blogs/



View Post: TortsProf Blog: Guest Blogger Ben Zipursky on "The Differential ...
23 Nov 2009 by tortsprof  
Riegel – like most medical device cases (I believe … but would be happy to be corrected) – is a design defect case. Wyeth – like most prescription drug cases – is a failure-to-warn case. That means that, at a gestalt level (and, ... That is , in part, because courts are willing to empower juries to second-guess experts on normative decisions about how much safety information should be disclosed. This is the so-called “patient rule” rather than the “physician rule.” ...
View Blog: TortsProf Blog - http://lawprofessors.typepad.com/tortsprof/



View Post: Mike Havrilla on CLDA - Clinical Data Inc - SocialPicks
6 hours ago by Mike Havrilla  
Study results suggest that vilazodone was generally well-tolerated and the efficacy and safety data were consistent with the findings from the previous Phase 3 trial. Clinical Data intends to file these data as the second of two positive ... The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); ...
View Blog: SocialPicks.com: Recent Picks - http://www.socialpicks.com/



View Post: Researcher develops biodegradable stent for hearts patients
21 hours ago by Ians  
Medical device maker Boston Scientific said Monday it received European marketing approval for its latest drug-coated stent technology, which prevents blocked arteries. Faulty 'wiring' in the brain turns schizophrenia on. October 27th, 2009 WASHINGTON - A new study, ... The company announced Wednesday there was no difference in safety complications after one year between diabetic patients with a Xience drug-coated stent, versus Boston Scientific's Taxus Express stent. ...
View Blog: Health News - http://blog.taragana.com/health/



View Post: The Legal Infrastructure of Business: Boston Scientific Still ...
12 hours ago by Paul Nashert  
In December of 2003, Peter Nicholas and John Abele, the founders of the medical device maker Boston Scientific, were riding high. Combined, the two owned approximately $9.9 billion worth of company stock, at a market value of $45 per share. ... ... recently paid $716 million to Johnson & Johnson to settle legal issues related to related to heart stents and having also paid $431 million in damages to a Texas radiologist for a patent violation related to drug coated stents. ...
View Blog: The Legal Infrastructure of Business - http://picker.typepad.com/legal_infrastructure_of_b/



View Post: Houston Style Magazine » UT Health Science Center is part of new ...
23 Nov 2009 by Style News Wire  
A new nonprofit Web site called ResearchMatch.org is making it easier for people to participate in medical research studies. These studies play a vital role in the development of new drugs and medical devices. ... Only treatments having acceptable safety profiles and showing the most promise may be considered for human use, the Food and Drug Administration reports. The Web site is a win-win situation. Volunteers, some with rare and hard-to-treat conditions, can access the ...
View Blog: Houston Style Magazine - http://www.stylemagazine.com/



View Post: Legal Theory Blog: Foley on Privatizing FDA Review of Medical ...
17 Nov 2009 by Lawrence Solum  
Considers the implications of privatizing the Food and Drug Administration's (FDA) review of the safety and efficacy of medical devices and drugs. Concludes that the FDA's flaws - namely, a risk avoidance culture and autocratic style of ...
View Blog: Legal Theory Blog - http://lsolum.typepad.com/legaltheory/



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November 26, 2009



Page Updated: September 6, 2005
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