Caffeinated Gum Causes New FDA Investigation
Updated Daily – Read our latest FDA, cGMP Compliance News Wrigley came out with a new caffeinated gum in early May that is called Alert Energy, which is yet another new food/beverage that is now featuring caffeine for additional energy in its users. However, FDA is investigating the new gum. FDA decided to take a […]
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J&J Stops Tylenol Production in South Korea
Updated Daily – Read our latest FDA, cGMP Compliance News Johnson and Johnson has come up with a new PR campaign to help us overlook the huge number of recalls and scandals in recent years. But no PR campaign is going to be a substitute for improving GMP manufacturing procedures. And these mistakes just keep […]
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Scandal Over Conflict of Interest for Novartis Trial
Updated Daily – Read our latest FDA, cGMP Compliance News There is a scandal regarding clinical trials done by researchers in Japan for a drug sold by Novartis that is getting bigger. Novartis is acknowledging for the first time that it is conducting an investigation because a Novartis employee may have worked on a clinical […]
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Why So Few FDA Warning Letters?
Updated Daily – Read our latest FDA, cGMP Compliance News One of the favorite activities for some bloggers is to write about FDA warning letters and what sorts of patterns we can discern by the warning letters that are issued. If you look at some charts of the most recent warning letter activity, we do […]
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Did Judge Go Too Far on Plan B Pill?
Updated Daily – Read our latest FDA, cGMP Compliance News A month after a US federal court mandated that FDA has to make the morning after pill available for sale without a prescription within thirty days, the Obama administration has now filed a motion to suspend the ruling until a ruling can be made on […]
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Novartis Dumps OTC Drugs Produced at 483-Plagued Nebraska Plant
Updated Daily – Read our latest FDA, cGMP Compliance News As part of the plan to reduce manufacturing operations at its 483-plagued plant in Lincoln, NE, Novartis sold the rights in the US to six of its OTC drugs. Five of them were produced at the troubled plant in Nebraska. The sale was made final […]
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FDA Wants Help on Think Tank for Opioid Trials
FDA wants the help of the Clinical Trials Transformation Initiative to help it deal with the problems of abuse and addiction that are being caused by prescription painkillers. That Initiative is a think tank that was created by FDA with the help of both academic and industry stakeholders. As in the past with this think […]
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Got MS? Have a Free Lunch on Novartis
Updated Daily – Read our latest FDA, cGMP Compliance News It looks like the fight for a share of the market for multiple sclerosis drugs is getting hot. Biogen Idec launched its Tecfidera drug recently for the disease, and there has been a shocking 125% increase in prescriptions in only 14 days. Now Novartis is […]
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Raised Eyebrow Alert – High Level FDAer Leaving For Mylan
Updated Daily – Read our latest FDA, cGMP Compliance News Earlier today we reported on the FDA Deputy Commissioner at FDA for Global Operations and Policy Deborah Autor leaving the agency and taking a senior management role at Mylan Pharmaceuticals. While it is very common for former FDA personnel to leave the agency and work […]
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FDA Deputy Commissioner Moves On to Mylan
Updated Daily – Read our latest FDA, cGMP Compliance News Deborah Autor, Deputy Commissioner at FDA for Global Operations and Policy, is leaving the agency and will take a job with Mylan Pharmaceuticals. It is common for FDA personnel to leave the agency for private sector jobs, but this is a very high profile move […]
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