Why A Boehringer Unit Really Has Drug Shortages
For the past several months, physicians and hospitals have bemoaned a growing shortage of various drugs, notably to treat cancer. The problem, which has prompted legislation in the US Senate, has contributed, in some cases, to rising prices and increased prescribing errors . New Webinar – July 28 – Dangerous Documents: How to Avoid Landmines […]
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Embattled wipe-maker responds to federal injunction
The Wisconsin firms accused of making and distributing alcohol wipes and other medical products potentially tainted with life-threatening bacteria say they view the permanent injunction filed against them as a step toward resuming operations. “This is the all-important first step in resuming our manufacturing operations,” said Eric Haertle, president of H&P Industries, in a press […]
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Federal action bars Wisconsin company from making or distributing health care products
Federal regulators have taken legal action to bar a Wisconsin company from making or distributing its health care products, following five recalls of disinfectant wipes and other health care products. The Food and Drug Administration said Monday that federal prosecutors filed a legal injunction against the Triad Group and H&P Industries of Hartland, Wisconsin. Once […]
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UCB Pays $34M To Resolve Off-Label Charges
Yet another drugmaker has been tagged for illegal marketing. This time, the US subsidiary of Belgium’s UCB has agreed to pay more than $34 million to resolve civil and criminal charges surrounding off-label promotion of its Keppra epilepsy drug, the US Department of Justice disclosed. Under the terms of the plea agreement in the US […]
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FDA Limits High-Dose Zocor Over Muscle Damage
More than a year after issuing a warning that the highest dose of the Zocor cholesterol pill could cause serious muscle damage (see here), the FDA is now saying the 80 mg dose should be avoided, except by patients who have taken this dose for 12 months or more and not experienced any muscle problems. […]
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Quote Of The Day: A ‘Detestable’ Johnson & Johnson
In explaining his decision to penalize Johnson & Johnson a healthy $327 million for deceptive marketing of its Risperdal antipsychotic, South Carolina Circuit Court Judge Roger Crouch late last week made a point of reciting a part of the famed credo that is religiously repeated by execs at the health care giant: “We believe our […]
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What Does it Mean to Operate in a State of Control?
Once upon a time, I asked this question of a senior management group at an off-site “strategy†meeting. You know—one of those meetings where a working breakfast was followed by a day of golf, and I was the one doing the working. New Webinar – July 28 – Dangerous Documents: How to Avoid Landmines in […]
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FDA Data Prompts Pfizer to Suspend Poultry Drug
A commonly used animal drug is being suspended from sale in response to new U.S. Food and Drug Administration data showing it increases arsenic levels in chicken livers. Though public health and industry experts stress that the levels of arsenic found in the new FDA study were very low, and that eating poultry treated with […]
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FDA Steps in to Prevent Drug Shortages
The FDA was able to prevent 38 “close calls” from turning into drug shortages last year by speeding approval of manufacturing changes or forewarning drugmakers. It’s also facilitated the import of drugs not approved for use in the U.S. to maintain supplies of medically necessary treatments. FDA spokeswoman Shelly Burgess says in an email that […]
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Learn About Latest FDA 483s and Warning Letters with FDA Digest!
FDA Digest Our e-newsletter FDA Digest is the industry leading resource and keeps you informed on: Recent 483s; The latest warning letters; and Breaking FDA regulatory news Can’t wait? Choose a free sample from below! Free newsletter #1 April 2010 – (PDF) featuring 483s on Baxa Corp, American Hormones, Ohm Labs, and Hospira warning letter […]
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