Novartis Admits It Did Wrong in Diovan Trials
Latest FDA and cGMP Compliance News Novartis recently opened an internal investigation on clinical trials in Japan that were done for its blood pressure drug Diovan. The company has come clean and admitted wrong doing. In a statement on the corporate website, the firm stated that two of its workers were involved in clinical trials […]
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Hidden FDA Agenda for Avandia Meeting?
Latest FDA and cGMP Compliance News In June, FDA is going to have a two day meeting to talk about clinical trial results for the Avandia diabetes drug, which comes three years after FDA majorly restricted the use of the pill. Steve Nissan, who was the co-author of a meta analysis that found higher heart […]
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J&J Tylenol Recall Disaster in Brazil
Latest FDA and cGMP Compliance News No matter how much Johnson & Johnson tries to get its cGMP manufacturing problems behind it, the company just cannot seem to escape them. The latest problem is being reported in Brazil, where over three million bottles of Tylenol Drops have been recalled. The dripper appears to not work […]
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FDA Inspectors Give 483s to 7 of 10 Dietary Supplement Firms
Latest FDA and cGMP Compliance News In a three year period, FDA cited seven out of every 10 facilities that produce dietary supplements for violating cGMP regulations. Of 626 FDA cGMP audits, 444 resulted in the issuance of a 483. The companies that got a 483 from 2010-12 were cited for 7 observations on average. […]
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Upcoming FDA cGMP Expertbriefings
Upcoming FDA cGMP Expertbriefings.com Webinars for 2013 include: May 30 – How to Survive PREDICT – FDA’s New Import Screening Program May 30 – The Essentials of Complaint Handling and Post Market Management – How to Comply With Global Regulatory Requirements May 30 – Audit Your Lab Like an FDA Auditor – A Roadmap to […]
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Major Shake Up at Boehringer After Warning Letter Disaster
Latest FDA and cGMP Compliance News Due to a long list of serious cGMP manufacturing problems, Boehringer Ingelheim is doing a major overhaul of its management team. Last week, the firm quietly put up on its website that a member of its board of managing directors – Wolfram Carius – is leaving the company after […]
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J&J Soul Searching – Help Us With Our Credo
Latest FDA and cGMP Compliance News After many scandals and investigations over cGMP violations and many recalls, not to mention several issues over marketing tactics, J&J is now engaging in some soul searching. The health care company is now asking its employees to reflect upon their thoughts about the credo for the organization, and […]
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FDA Set to Regulate Fecal Transplants
Latest FDA and cGMP Compliance News FDA has decided this week that fecal transplants are indeed biologic therapy, so this means that doctors and researchers will have to submit an IND application. Researchers who want to perform fecal transplants, which is emerging as a good therapy to treat Clostridium difficile or C. diff infections, were […]
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Actavis Departs to Ireland for Lower Taxes
Latest FDA and cGMP Compliance News If there is anything we can learn from the $9 billion deal that has Actavis buying Warner Chilcott, it is that taxes really do matter. As part of the deal, Actavis is going to place its headquarters in Ireland. In that country, the drug maker can pay a lot […]
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Bristol Myers Hit With Fine for Monkey Deaths
Latest FDA and cGMP Compliance News The Department of Agriculture has fined Bristol Myers Squibb for breaking the Animal Welfare Act due to the deaths of two monkeys in its labs. This fine was just revealed by PETA this week. That organization filed a complaint with FDA in 2012 after a whistleblower […]
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