Ranbaxy Slammed With Another Nasty 483
Latest FDA and cGMP Compliance News While Ranbaxy Labs did get some good news this week on one front, things have turned ugly yet again on the cGMP front. The troubled drug company, which has just had to pay $500 million to settle criminal and civil charges with FDA, received another bad 483 report for […]
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Indian Court Tosses Criminal Suit for Ranbaxy Labs
Latest FDA and cGMP Compliance News Ranbaxy Laboratories is finally enjoying some good news this week. The Supreme Court in India is tossing out a very publicized lawsuit that was aiming to criminally prosecute all current and former executives of the generic drug company. It also was aiming for restricted marketing of products and the […]
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FDA Cracking Down Harder on Indian cGMP Problems
Latest FDA and cGMP Compliance News The Indian pharmaceutical industry is facing major concerns, as more drug recalls FDA warning letters and import alerts are announced. Ranbaxy Laboratories pleaded guilty recently and paid hundreds of millions of dollars in fines but the crack down on Indian companies seems to be getting more intense. After the […]
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Maine Legislature Votes To Allow Drug Imports from Foreign Pharmacies
Latest FDA and cGMP Compliance News The Maine legislature has been debating for months about how to allow citizens to access more affordable medicines. Now the legislature has voted in favor of a proposal that will let state residents buy prescription drugs from foreign mail order pharmacies, including the UK, Canada, Australia and New Zealand. […]
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AMA Fights Fat and Boosts Pharma with Obesity Decision
Latest FDA and cGMP Compliance News This week, the American Medical Assn. stated that obesity is actually a disease. This is a controversial move that will probably boost demand for prescription diet drugs. The AMA is not able to require specific prescriptions, but the decision is a sign to doctors that they should get more […]
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Cephalon Reps Shown Trays of Cash to Promote Off Label Use
Latest FDA and cGMP Compliance News In 2010, an ex-manager at Cephalon filed a lawsuit and blew the whistle on the alleged illegal sales of 2 drugs – the painkiller Fentora and the treatment Treanda, which is for leukemia. This caused the US attorney’s office in New York to start an investigation of Cephalon, which […]
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China Blasts J&J Over Product Recalls
Latest FDA and cGMP Compliance News In the latest controversy over the product recalls with Johnson & Johnson, the Chinese government is blasting the firm for its poor quality control and for not pulling some products that have been pulled in other markets around the world. In early June, the China Food and Drug Administration […]
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Eli Lilly Fighting Scam Artists Over Illegal Name Use
Latest FDA and cGMP Compliance News Eli Lilly is a huge name in pharmaceuticals, so it is not surprising that some scammers want to use the name for their own purposes, but Lilly is not pleased. The company has informed federal authorities that scammers are using the name Eli Lilly and Elanco Animal Health to […]
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USSC Says that Pharma Companies Can Be Sued for Pay to Delay Schemes
Latest FDA and cGMP Compliance News After many years of debate in the industry, the US Supreme Court ruled recently that pharmaceutical companies can be sued for pat to delay patent settlements. However, it also stated that the deals should not be always viewed as against the law. In such a deal, a brand name […]
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FDA Probes Deaths of Zyprexa Patients
Latest FDA and cGMP Compliance News FDA is now looking into the mysterious deaths of two people who had been injected with Zyprexa, which is an antipsychotic drug that is marketed by Eli Lilly. Each subject died within a few days of the injection. FDA noted that the deaths occurred several days after the three […]
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