Lawyer Fights With FDA on J&J Risperdal Court Papers
Latest FDA and cGMP Compliance News A lawyer is pushing FDA to try to obtain documents that supposedly show unpleasant side effects of the antipsychotic drug Risperdal. But the documents cannot be released to the public because of a court order. The papers were sealed by a judge in Pennsylvania in a case involving […]
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China Arrests Dozens of Glaxo Employees in Epic Scandal
Latest FDA and cGMP Compliance News The very serious tax evasion and bribery scandal that has engulfed GlaxoSmithKline in China has resulted in the arrest of more than 30 employees. Among that number is at least six executives who are being confined to their homes. One of them is the legal counsel for GSK and […]
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Hikma Hit With FDA Warning Letter, West Ward Plant Closes But Reopens
Latest FDA and cGMP Compliance News The pharmaceutical company Hikma has been battling serious cGMP problems at its West Ward Pharmaceutical facility in Eatontown NJ, and Hikma did need to close down the plant earlier this year due to the problems, but it has since reopened. Hikma noted in its recent quarterly report that FDA […]
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GSK Workers in China Admit to Bribery
Latest FDA and cGMP Compliance News The GSK drama that has been ongoing in China in recent weeks became more serious, as several top executives confessed to crimes of bribery and tax-related crimes. This is according to the Ministry of Public Security in China. The statement from the ministry describes the offenses as very serious […]
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Frensenius API Plant Gets FDA Warning Letter
Frensenius Kabi got a warning letter this week from FDA for cGMP violations at its API plant in India. The letter was received on July 1 and was due to an FDA cGMP inspection that was done in Jan. 2013. Several cGMP regulations were broken at the oncolytic API facility that is located in Kalyani, […]
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Europe Devises Water Pollution Watch List for Drugs
Latest FDA and cGMP Compliance News Due to growing concern over prescription drugs leaching into water supplies, the European Parliament has put three pharmaceutical compounds on a watch list of pollutants, and these could at some point be put on a top priority list of known, dangerous pollutants. The 3 compounds are: Diclofenac – […]
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MHRA Bans Wockhardt from Making Drugs for European Market
Latest FDA and cGMP Compliance News Another drug maker in India is having problems with regulators. This time, the problem is with Wockhardt, and the Indian drug company has now been barred by the Medicines and Healthcare Products Regulatory Agency in the UK from making drugs in Europe. This move comes right after the UK […]
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FDA Planning Big Changes to Generic Warning Labels
Latest FDA and cGMP Compliance News With the fast track approval system that Congress set up for generic drugs, people who are hurt by a big name drug can be compensated from the drug company, if they can prove that the drug was dangerous and the label did not have a proper warning. But people […]
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Merck Gets Big Preemption Win
Latest FDA and cGMP Compliance News This is a decision that will hearten many in the pharmaceutical industry. This week, a federal court ruled that drugmakers can defend themselves against a lawsuit of product liability by using the concept of preemption – which is the idea that FDA approval of a medical product shall supercede […]
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GSK Investigates Illegal Sales Practices for Botox
Latest FDA and cGMP Compliance News GSK is now investigating if doctors were given bribes to prescribe Botox, and if they encouraged 12 employees to utilize private email accounts to cover up the activities. These allegations appear to be from the same anonymous tip that prompted GSK to launch a review last month of Chinese […]
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