Baxter Fined For Worker Death & Safety Violations
How is this for grave conditions in the workplace? A Baxter Healthcare unit was fined $371,250 for “deliberate and willful†safety violations that resulted in the death of a technician and serious injury to two others, according to the California Division of Occupational Safety and Health. All together, there were four willful citations issued, indicating […]
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FDA Issues Alerts on the Heart Drug Multaq
American and European regulators issued safety alerts on Thursday about Multaq, a drug approved two years ago to treat abnormal heart rhythms. The Food and Drug Administration said a study of the drug in patients with a long-term form of the disease, known as atrial fibrillation, showed twice as many deaths as those who did […]
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EMA Issues Cancer Warning About Actos
Although France and Germany suspended use of the Actos diabetes pill, the European Medicines Agency has decided to take a more conservative approach and today recommended that Takeda Pharmaceuticals simply place new warnings about possible links to bladder cancer. New Webinar, Sept. 28 – Prepare for An FDA Pre-Approval Inspection – FDA Investigator Perspective Your […]
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FDA to scrutinize mobile medical apps
The US Food and Drug Administration (FDA) is seeking input on its proposed oversight of some health-related mobile phone apps. New Webinar, Sept. 28 – Prepare for An FDA Pre-Approval Inspection – FDA Investigator Perspective Your Speaker: Martha Bennett, RAC, former FDA auditor under 3 Commissioners It’s hardly surprising that health-related apps are popular on […]
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J&J Special Committee: There Was No Wrongdoing
In an eagerly awaited report, a special committee of the Johnson & Johnson board has concluded that, despite manufacturing gaffes that caused countless product recalls, government investigations into off-label marketing and bribes paid to overseas officials, there were no red flags or indications of systemic failure that were overlooked by the board or executive team. […]
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Pfizer Facebook Page Is Hacked By Script Kiddies
Will this prompt Pfizer to abandon Facebook? The drugmaker was already trying to sort out a recent rule change that will no longer allow drugmakers to disable comments posted on newly created pages. And existing pages will no longer be able to do so as of August 15. Unlike a couple of rivals, Pfizer insisted […]
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AstraZeneca Falls in London; FDA Panel Rebuffs Diabetes Drug
AstraZeneca Plc (AZN), the U.K.’s second- biggest drugmaker, fell as much as 1.4 percent in London trading after failing to win the backing of a U.S. panel to sell an experimental diabetes treatment. The effectiveness of the medicine, dapagliflozin, in reducing blood sugar doesn’t outweigh risks of bladder and breast cancer, advisers to the Food […]
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FDA advisors vote against new diabetes drug; Astrazenaca stock drops
A US Food and Drug Administration (FDA) advisory committee has recommended against the approval of dapagliflozin, a diabetes drug that acts by increasing the body’s excretion of sugar. The final vote was six in favor and nine against the notion that the efficacy and safety data gathered by Bristol-Myers Squibb and AstraZeneca, the drug’s developers, […]
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FDA Is Urged To Suspend Trials Of Novartis Drug
In letters to the FDA and the Office for Human Research Protections, Public Citizen charges that clinical trials being run by Novartis for its Ilaris medication – which is approved for treating several rare and serious genetic disorders – should be suspended. Why? The watchdog group says Novartis is taking a “shotgun approach†to its […]
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Are Commitments Made to FDA to be taken Seriously?
Responses to FD483’s and Warning Letters are usually fully of commitments. They involve “what†will be done to correct compliance problems, and “when†it will be done. FDA has even started to ask “how†they will be done, meaning— Do you have the resources to do the work? Best Selling Webinar 2010 – July 21 […]
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