Greed Destroys New England Compounding Center
Which FDA District Offices Are Most Aggressive? For the past few months, the New England Compounding Center, the pharmacy that has been linked to 720 cases of fungal meningitis, and as many as 58 deaths (see this), has been battered by government probes, bankruptcy and civil lawsuits. Not surprisingly, one of the owners pleaded the […]
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Eisai Rips German Regulators
A Classic FDA Inspector Trick Drugmakers are known to chafe at regulatory decisions over approvals and, in Europe, coverage matters, but Eisai is now the latest to lash out at German regulators over reimbursement. The German Federal Joint Committee, which is the reimbursement agency, yesterday decided that Fycompa, a first-in-class treatment for uncontrolled partial epilepsy, […]
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The Silent Treatment and Other Classic FDAer Tricks
March 19, 2013 We hear a lot about tricks that FDA auditors like to use to get information out of companies. One of the most common is when they give you ‘the silent treatment’ during the inspection or at the conference table. The idea is for them to be quiet and wait for you to […]
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Big FDA Challenges Ahead in 3D Printing and Nanobots
3D Printing and Nanobots – FDA Challenges Ahead Among many products, the US Food and Drug Administration (FDA) regulates medical devices such as stents and prosthetics. FDA regulations – and compliance – are predicated on an assumption that medical device production is an involved undertaking that requires expertise, monies, and physical manufacturing. Yet, what would […]
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Ex-FDA Chemist Debarred for Huge Insider Trading Scandal
The $50,000 FDA 483 Response Mistake – Happens All the Time! Two years ago, FDA chemist Cheng Yi Liang was arrested for using confidential information about upcoming announcements of 27 different approval decisions involving 19 publicly traded companies over a five-year period. In the process, he generated more than $3.7 million in illegal profits for […]
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GSK CEO Pay Slashed in Half
March 7, 2013 The $50,000 FDA Compliance Mistake…. The chief executive at GlaxoSmithKline, Sir Andrew Witty, is going to have his pay cut big time this year, because of major declines in the group’s sales in Europe in 2012. His bonuses, which are tied to his performance and are about 70% of his pay, were […]
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Merck Slashes 280 Jobs in Ireland
March 7 2013 The word is that 280 jobs are being cut in Co. Wicklow in Ireland at a Merck plant. Staff at the plant in Rathdrum were called into a meeting to talk about the cuts yesterday. It is though that these pharmaceutical job cuts are part of a global reduction in costs at […]
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Managers: Spend $14,000 on a Mock Audit, or $480,000 on a Warning Letter Clean Up?
March 24, 2013 It might seem obvious, but the role of senior company leadership in FDA compliance is to really participate in the company’s quality system design and oversight. You need to ensure continual improvement of all of your quality system operations. One of the reasons this is so true is that according to recent […]
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Top FDA 483 Citations – Recent Data, Plus More 806 Enforcement
March 6, 2013 Our recent excellent FDA compliance speaker, Dennis Moore, President, AUK Technical Services, had some great data on the latest FDA compliance trends, including the most common areas where companies are getting 483s. If you’ve ever dealt with the agency, you know how difficult it can be to extract recent data from them […]
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Judge Slams Roche for Recusal Request
In rather stark terms, a New Jersey state court judge recently rejected a request by attorneys for Roche who accused her of bias in long-running and sprawling litigation over the Accutane acne medication. And in her remarks, Superior Court Judge Carol Higbee maintains that she has worked hard to appear even-handed despite several instances in […]
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