Alexion gets FDA warning but doesn’t expect Soliris disruption
Alexion is facing a tough situation for a one-hit wonder. It has been issued an FDA warning letter for its manufacturing plant where it makes its only approved drug–the rare-disease, and very pricey, Soliris. The company says it has backup manufacturing and inventory and believes it has the matter in hand, which at least one […]
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Killer Surgery Robots? FDA Probe Begins
The biggest thing in operating rooms these days is a million-dollar, multi-armed robot named da Vinci, used in nearly 400,000 surgeries nationwide last year — triple the number just four years earlier. But now the high-tech helper is under scrutiny over reports of problems, including several deaths that may be linked with it, and the […]
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Pfizer Hit With Warning Letter For Serious cGMP Manufacturing Problems
More Exclusive FDA and cGMP News April 10, 2013 FDA sent a serious warning letter to an Italian Pfizer plant this week. According to the letter, Pfizer violated some very basic cGMP regulations. One of the most serious was with its testing of samples of batches of a certain diluting agent, which was for its […]
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FDA Bashed for Failing to Pursue Bad Compounders
Exclusive cGMP/FDA News and Compliance For the past several months, the FDA has been widely criticized by Congress and others for not doing more to crack down on the New England Compounding Center, the now-bankrupt pharmacy tied to a nationwide outbreak of fungal meningitis that has led to 53 deaths (see this).  Since the scandal broke, the […]
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Pfizer Warning Letter For Cardboard in Drug Samples
Exclusive cGMP/FDA News and Compliance In its latest bid to clamp down on wayward drug manufacturing, the FDA cited a Pfizer plant in Italy for violating some fairly basic procedures. The first involved problems with testing samples of batches of a diluting agent for its Torisel kidney cancer drug and claiming false positives were caused […]
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Yet Another J&J Product Recall Mess
As the saying goes: Another day, another Johnson & Johnson recall. The latest involves the 2020 Insulin Infusion Pump sold by the Animas unit for treating diabetes. A “component” issue is causing the device to sound a false alarm and when that happens, the pump may prompt the user to incorrectly follow the usual sequence […]
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Roche Makes Tamiflu Data Available
In an effort to appease the growing clamor for Tamiflu clinical trial data, Roche has agreed to make available data from all 74 clinical trials for its treatment to a team of Cochrane Collaboration researchers. The move comes after the the drugmaker recently agreed to widen access more generally for clincal trial information for its medicines […]
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Astrazeneca In Trouble, Says S&P
Three weeks ago, Pascal Soirot unveiled a months-long effort to rebuild AstraZeneca, which he joined last fall as ceo amid a disheartening lack of new drugs and increased generic competition. His plan revolves around consolidating R&D and global marketing operations over the next two years, a move that will eventually eliminate 1,600 jobs by 2016 […]
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Kabco Pharma Fighting for Its Life
Exclusive FDA News and Compliance Tips Contract manufacturer Kabco Pharmaceuticals must halt production of dietary supplements until it proves its facilities are in compliance with dietary supplement good manufacturing practices (GMPs), according to a consent decree signed by FDA and Kabco, and approved April 4 by Jospeh Bianco, a federal judge in the U.S. District […]
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McConnell calls on FDA to address ‘pain pill epidemic’
April 10 – Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission Senate Minority Leader Mitch McConnell (R-Ky.) asked the Food and Drug Administration (FDA) to ensure that generic painkillers are tamper-proof to prevent abuse. FDA eCopy Tips! “I believe more can be done to prevent an influx of generic opiates […]
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