FDA Warns Website For Selling ‘Professional Cialis’
The barrage of prescription meds being peddled by websites is spurring the FDA to go after bogus operators who are apparently located in Ukraine, Panama, New York or who-knows-where. Of course, whether the warning letters issued last week to two such operators will ever be received is unclear – there is so much confusion about […]
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Every registrant for one of our Expertbriefings.com Webinars receives: GotoMeeting Webinar Recording (download or a CD can be mailed to you) Power Point Slides to Print 6 months of Cerulean Associates’ Smart Compliance e-newsletter Cerulean Associates Quality by Design Guide Cerulean Associates Lean Compliance Guide Certificate of Attendance Credits for Your ASQ and RAPS certification […]
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Surviving a new era of FDA enforcement
Receiving a Warning Letter from the U.S. Food and Drug Administration is bad enough, but when those Warning Letters are published on the agency’s Web site where companies can read, print out, and use them for competitive advantage, the “incentive†is even greater for companies to take corrective action. Since 2009, FDA’s increased power and […]
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FDA Chemist Liang Faces New Insider-Trading Charges
U.S. prosecutors filed new charges involving an alleged insider-trading scheme against a Food and Drug Administration chemist, a move the government said in earlier court papers would be the prelude to a plea agreement. Cheng Yi Liang, who worked for the FDA’s Center for Drug Evaluation and Research, was charged today in federal court in […]
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FDA Still Reviewing Clot Risk for Birth Control Pills
Four months after announcing that it was reviewing the safety of certain drospirenone-containing oral contraceptives, following reports of heightened risk for blood clots, the FDA said Monday that it still had not reached a conclusion. Data from a large FDA-funded epidemiologic study have now undergone preliminary analysis and suggest a 1.5-fold increase in venous thromboembolism […]
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FDA Panel, Bayer Birth Control Pills & Blood Clots
Nearly six months after a pair of studies found that women taking birth control pills containing a hormone called drospirenone are more likely to develop blood clots than those who take an older oral contraceptive, the FDA has decided to hold an advisory panel meeting in December to review the risks and benefits. Meanwhile, the […]
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Cephalon Gets Subpoena For Treanda Marketing
The other shoe has dropped in the probe into Cephalon and its Treanda medication, which is used to treat chronic lymphocytic leukemia. The drugmaker has officially received a subpoena from the US Attorney in New Yrok requesting documents “pursuant to its authority†under the Health Insurance Portability and Accountability Act, according to a filing with […]
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The 340B Drug Pricing Program Needs A Big Fix
Is the 340B Drug Pricing Program broken? Maybe not entirely, but a big fix may be in order, according to a new report released by the US Government Accountability Office. After interviewing 61 participants, including drugmakers and hospitals, the GAO says the Health Resources and Services Administration Agency relies too heavily on self-policing to ensure […]
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Op-Ed: Pharma Layoffs & Small-Minded Survivors
As pipelines shrink and investors demand better yields, the downsizing has caused tens of thousands of pharma employees to lose their jobs over the past several years. These severe cutbacks, however, may yet take their toll on the pharmaceutical industry in another, more pernicious way. In the view of Dan Hoffman, big drugmakers are now […]
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Why The Little Biotech Dismissed Its CEO
A few weeks ago, Oxygen Biotherapeutics mysteriously dismissed ceo Chris Stern after stock market trading finished one day. There was little explanation offered at the time, other than an investigation by the board’s audit committee found problems with his “conduct†and its potential impact on the biotech, which is developing various products that would deliver […]
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