AMRI Hit With Another 483 in Burlington MA
Latest FDA and cGMP Compliance News FDA gave another 483 earlier this spring to AMRI, a contract manufacturing organization (CMO) in Burlington MA. The company has gotten two 483s from FDA in recent years. The new 483 had three new observations after a seven day site visit. Albany Molecular Research noted in a press release […]
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Congress Needs to Clarify FDA Authority For Compounding Pharmacies
Latest FDA and cGMP Compliance News Congress is continuing to get ready to mull highly controversial legislation to tighten oversight of compounding pharmacies, and a new Government Accountability Office report is largely confirming FDA’s stance – the authority of FDA to regulate these organizations is not clear. This is because of various court rulings and […]
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Valeant CEO Ripped by New York Politicians for Moving HQ
Latest FDA and cGMP Compliance News Moving employees from one location to another after an acquisition in the pharmaceutical industry is not unusual. Still, the announcement in July that Valeant Pharmaceuticals intends to move Bausch and Lomb HQ and its eye care business to New Jersey from Rochester NY has many politicians in an uproar. […]
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Lower Irish Tax Rate Closes Perrigo/Elan Deal
Latest FDA and cGMP Compliance News For the 2nd time in the last month, Ireland has shown up in the acquiring of one drug firm by another. The reason for this is very clear. Because the firm is locating the HQ in Ireland, the formerly US-based company will enjoy lower corporate taxes. The most recent […]
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Valeant Chops 2850 Workers After Recent Bausch and Lomb Deal
Latest FDA and cGMP Compliance News Valeant Pharmaceuticals has started to digest its $9 billion of Bausch and Lomb, about 2850 jobs are going to be chopped from a workforce of about 20,000 workers, as the firm is trying to save about $750 million over the next 18 months. This information was released to employees […]
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Mckesson Plans to Fight Clawback Policy
Latest FDA and cGMP Compliance News Do you think one of the biggest drug wholesalers should have a clawback rule for top executives? Two investors think the time has come for McKesson, as the wholesaler has had to pay out more than one billion dollars in recent months to deal with various legal disputes without […]
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EMA Says No Pancreatic Cancer Risk with Diabetes Drugs
Latest FDA and cGMP Compliance News The European Medicines Agency has decided that there is not any evidence to confirm recent theories that commonly used diabetes drugs, called GLP-1 inhibitors, has any link to pancreatic cancer. This review was done in response to a controversy about a study that was published in the magazine Diabetes […]
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Chinese Authorities Release More Sordid Glaxo Scandal Details
Latest FDA and cGMP Compliance News There have been more developments in the bribery/sex scandal in China involving GlaxoSmithKline. GSK has now put Herve Gisserot, the senior vice president of its business in Europe, as the head of operations in China. His predecessor, Mark Reilly, is going to return to China in the next few […]
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Glaxo Telling Muddled Stories on Chinese Bribery Scandal
Latest FDA and cGMP Compliance News For the last month, GlaxoSmithKline officials have tried to look contrite and diligent as they try to control the damage from the massive bribery scandal in China. There, four senior employees were detained by authorities for allegedly participating in a scheme that involved paying hundreds of millions of […]
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IMS Health Accused of Eliminating Competition to Gain Monopoly
Latest FDA and cGMP Compliance News IMS Health is probably the leading company in the collection of data in the pharmaceutical industry. However, that company has a smaller rival, Symphony Health Solutions, that is now claiming that IMS has increased revenues and its base of customers illegally, the goal being to obtain a monopoly in […]
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