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Currently viewing the tag: "FDA"
Here’s a forgotten chapter from pharmaceutical history. The acne drug, Accutane, manufactured by Roche Pharmaceuticals, has been associated with hundreds of birth defects. Since 2005 the iPLEDGE program has required that patients, doctors, and pharmacists register and that patients prove they are on birth control before they can be prescribed this potentially dangerous drug. But [...]
This week President Barack Obama named Thomas Frieden MD as Director of the Centers for Disease Control and Prevention (CDC) in Atlanta, GA, and Dr. Margaret Hamburg as Director of the Food and Drug Administration (FDA) with Joshua Sharfstein MD as Deputy Director.
“Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness” – Justice John Paul Stevens
Wyeth, Drugmakers Lose as Top U.S. Court Allows Suits (Update1)
By Greg Stohr
March 4 (Bloomberg) — The U.S. Supreme Court bolstered patient lawsuits against drugmakers, upholding a $7 million award to [...]
In a sign of their undying loyalty to drug and device makers the Republicans have declared their opposition to a plan to add a billion dollars to the stimulus package to study the relative cost and effectiveness of different treatments for chronic conditions, a plan which President Obama is expected to sign tomorrow. I simply had to [...]
In this week’s edition of the British Medical Journal BMJ there are some articles on “Doctors, patients, and the drug industry” which include some typical “fair and balanced” he said-she said articles in which avators like Marcia Angell (doctors should cut ties with drug industry) and our old friend from Yale Harlan Krumholz [...]
There is an editorial in this weeks issue of JAMA by Drs. Sniderman and Furberg on the issue of medical guidelines, something that I have written about before, for example about how the National Cholesterol Education Panel (NCEP) came up with guidelines that would put 25% of the American population on statins, even [...]
I made up a little website of the who’s who list of drug disasters while researching my book on drug safety as a way to entertain myself.
At the time I thought it might offend some people, so I posted it on the internet, but without [...]
The pharmaceutical industry has been pretty aggressive about getting their products out to market, including such tactics as manipulative use of expert consensus guidelines to the use of former professional cheerleaders as drug reps.
As noted by the author of a recent book on pharmaceutical marketing “Hard Sell: Evolution of a [...]
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