More Glaxo Scandals in China – Bribing Doctors to Prescribe Meds
Latest FDA and cGMP Compliance News GlaxoSmithKline appears to be in the middle of another scandal in China. This time, the company is looking into accusations that some of its sales staff is bribing doctors to prescribe certain types of drugs. Sometimes this is done on an off label basis. GSK sales reps are supposedly […]
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Glaxo Fires Exec For Faked Data in Scientific Paper
Latest FDA and cGMP Compliance News After a long internal investigation, GlaxoSmithKline determined that a scientific research paper that was published in Nature Medicine had a considerable amount of faked data. It has now fired Jingwu Zang, who was one of the authors of the study, and who also was a VP and head of […]
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Walgreens Pays $80 Million for Controlled Substances Act Violations
Latest FDA and cGMP Compliance News There is a nationwide effort underway to cut down on the abuse of prescription painkillers, and Walgreens has gotten caught up in it now. Walgreens is the biggest pharmacy chain in the US, and it agreed this week to pay $80 million in penalties for violations of its license, […]
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Baxter Healthcare Receives Especially Nasty Warning Letter
Latest FDA and cGMP Compliance News FDA is continuing a rather aggressive crackdown on cGMP violations, and we are seeing a lot of tough warning letters being issued. But every month or two, we notice a warning letter that is particularly unpleasant, given the types of cGMP violations that are noted therein. The latest sample […]
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GSK HQ is a 10X10 Foot Office in…..Delaware
Latest FDA and cGMP Compliance News Most of GlaxoSmithKline’s US operations are based in Philadelphia, where about 2000 people work and there is 700,000 square feet of office space. GSK also has a 10 by 10 foot tiny office in Wilmington, DE that mainly has books and records and is rarely used. Only one employee […]
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Ex-Bristol Myers Executive Pleads Guilty to Insider Trading
Latest FDA and cGMP Compliance News An ex-Bristol Myers Squibb top executive pleaded guilty to the crime of insider trading this week. Robert Ramnarine, 46, admitted to buying stock options in several drugmakers that were to be acquired by BMS. This yielded the ex-director of pensions and savings more than $300,000 in profits. He […]
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When A Medical Device Company Crosses the Line Into Crime
Latest FDA and cGMP Compliance News Most of the time, when the Office of Criminal Investigation (OCI) at FDA gets involved in a case, it results in criminal and civil penalties. Recent examples include Abbott Laboratories and Amgen, where they both paid into the billions of dollars in fines to the US government. However, […]
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Bear Bile Drugs in China Cause Outcry
Latest FDA and cGMP Compliance News An IPO in China by a drugmaker that was using bile from trapped black bears to make drugs for the eye and liver has been scrapped. The decision came after more than 24 months of protests from animal rights groups. The Fujian Guizhentang Pharmaceutical stock program was one […]
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FDA Panel Votes to Ease Up Avandia Restrictions
Latest FDA and cGMP Compliance News A very intense two day FDA advisory committee meeting showed the many challenges in determining the best path to drug safety. In the end, FDA’s panel was divided but voted to let up on restrictions on the use of Avandia, the highly controversial diabetes drug. The pill had been […]
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GSK Probes Allegedly Fake Data Produced by Employees
Latest FDA and cGMP Compliance News GSK is currently investigating if a scientific paper from 2010 was written by several R&D scientists in China who used fabricated data. GSK also is putting at least one employee at this R&D center in China on leave while the probe is conducted. The paper appeared in Nature Medicine, […]
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