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Monthly Archives: February 2008
Preemption Watch: Legal Eagle Explains Riegel
The Supreme Court last Wednesday decided the first of an important series of cases having to do with whether FDA approval and regulation preempts lawsuits at the state level. The case was Riegel v. Medtronic, and it had to do with a balloon catheter that burst during an angioplasty. Though it’s a device case, not [...]
Posted in Legal, Regulatory Leave a comment
New Nonprofit Vaccine R&D, with love from Novartis
Salmonella. Typhoid. Shigella. Such are the diseases of the developing world. A few years back, eliminating these diseases was a non-issue for pharma—without any Western market, it didn’t register as a priority. But if you’ve followed the intersection of pharma and philanthropy over the years the way we have we have (on AIDS, TB, and [...]
Posted in Corporate Responsibility 1 Comment
A New Policy on Off-Label Promotion? Not Entirely.
“FDA Seeks to Broaden Range of Use for Drugs” read a headline in this past weekend’s New York Times. You’d be forgiven if you thought the article was about FDA trying to broaden the use of drugs—but in fact it was about something quite different: a new FDA draft guidance that would change the rules [...]
Posted in Legal, Marketing, Regulatory 1 Comment
HBA Names Woman of the Year
This just in: The Healthcare Businesswomen’s Association (HBA) just announced its Woman of the Year. (Better known as WOTY, for those in the inner circle.)
At this year’s luncheon, held on May 8 at the New York Hilton, HBA will hand the WOTY honor to Charlotte Sibley, senior vice president, leadership development for Shire. This [...]
Posted in People Leave a comment
Nasonex Named Most Recalled TV Ad