AbbVie Chops 100 Scientist Jobs
Latest FDA and cGMP Compliance News A month ago, AbbVie’s Chief Scientific Officer retired. Now the firm is making big changes in R&D. It will lay off about 100 scientists from the pain discovery division, specifically, in neuroscience, according to our sources. The changes in R&D are a small part of a large transformation at […]
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Age Discrimination Accusations at Shire
Latest FDA and cGMP Compliance News There are accusations at Shire Pharmaceuticals that the head of regenerative medicine was fooled into taking a promotion. Jeff Jonas is claiming in a new lawsuit that the biotech firm did not disclose that the unit he was moving to had dropping sales, and that there was a […]
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FDA Releases Draft Guidance on Contract Manufacturing
Latest FDA and cGMP Compliance News FDA this week released its draft guidance entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements’, which details the thinking of the agency on defining, establishing and documenting the responsibilities of all parties who are engaged in contract cGMP manufacturing of pharmaceuticals. This guidance tells us how parties that are […]
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New Compounding Pharmacy Scandal in TN
Latest FDA and cGMP Compliance News Last month, Tennessee passed a law that eased the restrictions on the state’s compounding pharmacies. Now FDA is looking into seven cases of patients suffering adverse events after they were injected with possibly contaminated drugs that were compounded by a TN pharmacy. That is why Main Street Family Pharmacy […]
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Greed and Post-Marketing Requirements Lead to Trouble for Shionogi
Latest FDA and cGMP Compliance News FDA told Shionogi that two clinical trials would be needed after it was found that there was a big risk of heart arrhythmia with the painkiller Rybix. FDA also told Shionogi that a draft protocol was needed in Feb. of this year and a final report would be needed […]
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Forest Labs CEO Retires, But Feds Issue Subpoena
Latest FDA and cGMP Compliance News Last year, Howard Solomon decided to step aside as the CEO of Forest Laboratories, but that’s when DOJ sent the firm a subpoena regarding its treatment for chronic obstructive pulmonary disease, known as Turdorza Pressair. The subpoena got the the company HQ on May 6, and Solomon announced he […]
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Ranbaxy Ignored Consultant Warnings About Major cGMP Problems
Latest FDA and cGMP Compliance News Many years before Ranbaxy Laboratories got into hot water with FDA over cGMP violations and the manipulation of data, many independent auditors and consulting companies told the drug maker to improve its quality systems, data documentation and procedures. Some of the consultants warned 10 years ago that Ranbaxy could […]
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FDA Slams Boehringer-Ingelheim With New Warning Letter
Latest FDA and cGMP Compliance News Boehringer-Ingelheim was hit with a warning letter for two API and two cGMP observations this month. Also, the API and drug facility in Germany was hit for its failure to respond with appropriate corrective actions after the first 483 it received in 2012. In the API area, FDA hit […]
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Impax Brings in Specialists to Fix cGMP Problems
Latest FDA and cGMP Compliance News Impax Laboratories has been faced with serious cGMP manufacturing trouble that caused FDA to reject its NDA for a new Parkinson’s disease treatment. So, Impax has hired several regulatory consultants to oversee manufacturing improvements at its plant in California. To improve its quality of operations, Impax brought in Leslie […]
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Ranbaxy Labs Blasts Salvo at Daiichi Sankyo
Latest FDA and cGMP Compliance News The Ranbaxy Laboratories mess is getting more interesting. A day after Daiichi Sankyo stated that certain ex-shareholders concealed vital information, and that legal options were being considered, the Singh family that sold Ranbaxy to Daaichi for $4 billion is getting nasty. The Singhs accused Daiichi of trying to shift […]
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