Did Glaxo Violate Corporate Integrity Agreement With China Trainwreck of Scandal?
Latest FDA and cGMP Compliance News The continuing train wreck of scandals at GlaxoSmithKline in China, such as bribes done by senior executives and clinical study failures, have led to investor anxiety, but shares are largely trading in the same range as before all the trouble started in May. GSK has said it is not […]
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PhRMA Ranked as Top Lobbying Group in DC – What Say You?
Latest FDA and cGMP Compliance News Many policymakers in DC think that the pharma industry is definitely getting its money’s worth for the dues they hand to PhRMA, the drug industry trade group. A recent survey of 500 policymakers in DC stated that the Pharmaceutical Research and Manufacturers of America is the best in 4 […]
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The Glaxo China Scandal – Bribes, Hidden Study Results and More
Latest FDA and cGMP Compliance News There are serious signs that the R&D operations in China for GlaxoSmithKline are a complete train wreck. The latest story is that researchers were failing to report animal study results on drugs that were being tested in humans, and employees failed to monitor clinical studies and they paid […]
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Urine Puddles and Destroyed Records – FDA Hits Wockhardt Hard In Latest Warning Letter
Latest FDA and cGMP Compliance News Over the years, we have seen a number of FDA warning letters that have some rather alarming and sometimes even amusing details about cGMP violations. But the warning letter that Wockhardt received on July 18 had some truly unusual practices and violations noted that are going to be watched […]
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Mallinckrodt Shells Out $3.5 Million to Settle Kickback Probe in Whistleblower Case
Latest FDA and cGMP Compliance News Just three days after the DOJ engaged in a whistleblower suit against the drug company Mallinckrodt, the firm agreed to a fine of $.35 million to settle the charges that it paid out kickbacks to doctors to encourage them to prescribe drugs. This illegal activity caused both the Medicare […]
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Damage Spreads for Glaxo in China Bribery Scandal – Execs Oversaw Bribes
Latest FDA and cGMP Compliance News More fallout is coming for GlaxoSmithKline in the bribery scandal mess in China. This past weekend, the drug company was scrambling on multiple fronts to limit the damage from the bribery scandal. The president of international operations, Abbas Hussain, met with authorities in China and issued a formal statement, […]
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Eli Lilly Enacts Pay Raise Freeze for Employees
Latest FDA and cGMP Compliance News A few months after it announced plans to lay off 1700 sales reps, Eli Lilly is going to suspend pay raises for the vast majority of employees in 2014, including executives and managers. It also is going to cut employee bonuses that are supposed to be paid out in […]
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Wockhardt Plant in India Gets FDA Warning Letter
Latest FDA and cGMP Compliance News Wockhart Ltd stated this week that it had received a warning letter from FDA for its plant in Waluj, Maharashtra, India. The plant did not meet several aspects of the GMP regulations. The company also reported in May that FDA had put out an import alert on the Waluj […]
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Bristol Myers Squibb Adding 579 Jobs in Tampa, Florida
Latest FDA and cGMP Compliance News A major factor in getting a better economy in the country is to always add jobs, and it is even better when those jobs are relatively high paying. So it is good news for Tampa Bay, Florida that Bristol Myers Squibb is coming to the area and will add […]
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Glaxo Execs Forced to Stay in China Over Bribe Accusations
Latest FDA and cGMP Compliance News There is more distressing news for GlaxoSmithKline coming out of China. At this point, the company is under investigation in China for giving bribes to health officials and doctors. At this time, four executives, all who are Chinese nationals, have been held there. One of the executives actually went […]
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