GMP Problems Result in 300 Jobs Chopped At Novartis Plant
Updated Daily – Read our latest FDA, cGMP Compliance News One way to deal with a 483 or warning letter for cGMP violations is to just chop operations. And that is exactly what Novartis is doing in Lincoln, Nebraska. About 18 months after Novartis admitted that it had major cGMP guideline problems at this […]
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More Evidence of Link Between Autism and Antidepressants
Updated Daily – Read our latest FDA, cGMP Compliance News A new study suggests that there could be a tentative connection between autism and antidepressant use by women who are pregnant. This latest study comes from an analysis of medical and birth registries in Sweden. It found that exposure in utero to SSRIs and anti […]
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Novartis Sued by Federal Government for Massive Kickback Scheme
Breaking FDA and cGMP Compliance News The US government is suing Novartis for allegedly providing kickbacks – rebates and discounts – to more than 20 pharmacies. They allegedly did this in exchange for changing transplant patients from competitors’ medicines to Myfortic, which is an immunosuppressant medicine. So, both Medicare and Medicaid paid too much based […]
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FDA Mulls Petition to Protect Patents for Biologic Medications
Updated Daily – Read our latest FDA, cGMP Compliance News Abbott Laboratories has expresses concern in recent months about the process of approval for generic biosimilar variations of biologic drugs (which are covered under cGMP 21 CFR Part 600). Recent opening salvos by Abbott on this topic could begin an intriguing legal battle between Big […]
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FDA Recognizes OxyContin Abuse With New Reformulation
Updated Daily – Read our latest FDA, cGMP Compliance News The FDA approval in recent weeks of a new abuse-resistant form of OxyContin is being seen by many in the pharmaceutical industry as a good indication of the agency’s awareness of the significant growth of OxyContin abuse to even an epidemic status. The abuse of […]
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FDA Wants to Use Data Mining to Find High Risk Drug Manufacturers
Updated Daily – Read our latest FDA, cGMP Compliance News We all know that the pharmaceutical supply chain is very complex and spans the globe. This makes it difficult for FDA to pinpoint who the bad companies are and which products are the most dangerous. Most APIs are imported from India and China and other […]
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Congress Preparing Legislation to Improve Pharmaceutical Supply Chain
Updated Daily – Read our latest FDA, cGMP Compliance News The US Senate Health, Education, Labor and Pensions Committee is putting together a draft bill with the goal of bolstering the supply chain for the pharmaceutical industry. This move is coming several months after they came out with a draft discussion on the topic to […]
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FDA Blasts Teva for Overblown Marketing Materials
Updated Daily – Read our latest FDA, cGMP Compliance News Most pharmaceutical companies are aware of all of the requirements for putting together marketing materials for their drugs. This includes submitting forms that spell out all of the marketing messages that are to be given. Teva Pharmaceuticals was hit hard by FDA this month for […]
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More Drug Compounding Recalls for Bacteria in Vials of Product
Updated Daily – Read our latest FDA, cGMP Compliance News A drug compounding firm in Tennessee is doing a voluntary recall of its entire line of sterile injectable drugs. This happened after FDA cGMP inspectors discovered strong evidence of bacterial contamination in vials of finished products. The recall was announced by FDA for Balanced […]
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Aptuit Employee Busted and Jailed for Clinical Trial Data Scams
Updated Daily – Read our latest FDA, cGMP Compliance News Last week, an ex-employee from the clinical research organization (CRO) Aptuit was given 3 months in jail. His crime was altering pre clinical trial data that was part of applications to do various types of clinical trials. This news came from the United Kingdom’s Medinces […]
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