FDA Calls in Calvalry on Yaz Safety Analysis
FDA has called in the cavalry for help reviewing the safety of Bayer’s Yaz line of birth-control pills. The agency plans to convene an advisory panel in December to sift through the evidence on the contraceptives–and their generic equivalents–which contain drospirenone, a synthetic version of the hormone progestin. And in the meantime, it’s warning women […]
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Qualitest Pharmaceuticals Issues a Nationwide Voluntary Recall of Oral Contraceptives
Qualitest Pharmaceuticals Issues a Nationwide Voluntary Recall of Oral Contraceptives Contact: Consumer: 1-877-300-6153 Media: Kevin Wiggins (610) 459-7281 FOR IMMEDIATE RELEASE – September 15, 2011 – Qualitest Pharmaceuticals today issued a voluntary, nationwide, retail-level recall of multiple lots of oral contraceptives. The recall is being implemented because of a packaging error, where select blisters were […]
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CSL Trying to Resolve FDA Concerns
Pharmaceutical company CSL says it has addressed the majority of manufacturing flaws highlighted by FDA and remaining concerns are currently being resolved. Audits carried out by the FDA in 2010 and 2011 revealed “objectionable conditions and practices” within CSL, News Ltd reported on Thursday. Allegations include the failure of laboratory staff to wear masks while […]
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FDA Enters Consent Decree Against FL Drug Companies
The U.S. Food and Drug Administration announced today that the District Court for the Middle District of Florida entered a consent decree that prohibits Hill Dermaceuticals, Inc., and Hill Labs, Inc. (collectively referred to as “Hill”), and individuals Jerry S. Roth and Rosario G. Ramirez, from introducing adulterated drugs into interstate commerce. The government’s complaint […]
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US economic woes “leading to risky Rx practices”
Financial pressures are leading more Americans to take potentially dangerous actions with prescription drugs, a new survey has found. At the US Consumers Union, the Consumer Reports’ National Research Center has for the last three years conducted an annual survey asking consumers about their medication and health care use, and this year, the percentage of […]
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Sanofi’s Questionable Allergy Test
Here’s a way to generate consumer interest in your over-the-counter allergy medicine – strike a deal with a supermarket chain that agrees to offer free allergy tests. Results are mailed within three weeks and those who test positive to such common allergens as wheat, egg, cat dander, ragweed or timothy grass get a personalized “Allergy […]
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Researchers Not Making Raw Study Data Available
Medical journals may urge researchers to make raw study data available publicly, but many researchers are still not doing so, according to recent study in PLoS One, which reviewed 351 paper from 50 medical journals that have the highest impact. The review found a wide variation in policies for sharing data and how researchers follow […]
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Merck Pays $1.5M Fine For Pollution Problems
For violating several federal environmental laws at two Pennsylvania plants, Merck has agreed to pay a $1.5 million civil fine and settle charges brought by both the US Environmental Protection Agency and the US Department of Justice. Since the drugmaker has already resolved the violations, though, the feds have filed papers to dismiss their original […]
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Judge questions images for cigarette packages
A federal judge peppered a government lawyer with questions Wednesday expressing doubts about whether the Food and Drug Administration can force tobacco companies to post graphic images on their cigarette packages showing the health effects of smoking. In a two-hour hearing, U.S. District Judge Richard Leon closely questioned Justice Department lawyer Mark Stern on whether […]
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Drug Shortages Prompt Legislation to Help FDA Confront Problem
Medicines that are critical to fighting cancer as well as anesthetics, electrolytes for intravenous drips, and emergency drugs are facing severe shortages in the U.S. The American Hospital Association surveyed 820 hospitals this summer and found that at least half experienced shortages with more than 20 drugs, and 75 percent started rationing drugs. [1] The […]
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