Could FDA Have Stopped the Bacterial Infections Traced to NECC?
Latest FDA and cGMP Compliance News Source: Pharmalot Is it possible that FDA could have stopped a bacterial infection outbreak that was traced recently to a compounding pharmacy? This is believed to be the case by a certain consumer watchdog that has noted that FDA issued a 483 report last year that showed that Specialty […]
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FDA Approves Two New, Promising HIV Drugs
Latest FDA and cGMP Compliance News We were pleased to see this week that FDA has issued two new drug approvals for HIV drugs that could offer new hope to people who are suffering from this deadly illness. CDC reports that 50,000 new cases of HIV occur every year, and about 16,000 people a year […]
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China Bribery Scandal Now Engulfs Novartis
Latest FDA and cGMP Compliance News The latest pharmaceutical company to get sucked into the China bribery scandal is Novartis. An ex-sales rep at the company has alleged that the company was offering bribes to physicians in some places to increase sales of Sandostatin LAR, which is designed to treat stomach cancers. The rep, as […]
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Source: West Ward Pharmaceutical Giving Bonuses Only to Non-Union Workers
Latest FDA and cGMP Compliance News Expertbriefings.com was contacted recently by a worker from West Ward Pharmaceuticals in Eatontown NJ, who was responding to our recent story about West Ward Pharmaceutical closing its doors temporarily in 2012. This source tells us that the company closed its doors in November 2012 with no warning at all […]
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Acorda Therapeutics Slammed With New Warning Letter for Ads
Latest FDA and cGMP Compliance News It seems that Accorda Therapeutics is again having problems with FDA. The firm now has had three letters from FDA in a year, two of which were warning letters. The latest violation is the second time in this period that the company has been chastised for improper advertisements for […]
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DCGI in India to Review cGMP Compliance for Ranbaxy Facilities
Latest FDA and cGMP Compliance News The Drugs Controller General of India (DCGI) is going to review the cGMP compliance of all manufacturing plants for Ranbaxy Laboratories in India, after the recent serious cGMP problems for Ranbaxy. Ranbaxy was fined $500 million by FDA for manufacturing certain drugs that were not in adherence to cGMPs. […]
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FDA Orders Acetaminophen Warning
Latest FDA and cGMP Compliance News Acetaminophen, which is the pain and fever reliever that is used in Tylenol, can cause serious skin problems and reactions in some people, FDA stated this month. The drug has now been linked to several specific skin problems and diseases:Â Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. […]
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Serious Novartis Scandal Causes Japan To Mull Penalties for False Data
Latest FDA and cGMP Compliance News After the big scandal regarding research for the blood pressure drug Diovan, the government in Japan is thinking about new laws to more tightly regulate clinical trials. The penalties for not preserving and submitting the records to the Japanese government would include a good number of fines, having the […]
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Television Ads for Statins Cause Overdiagnosis and Prescribing
Latest FDA and cGMP Compliance News Are TV ads for pills that lower cholesterol causing an epidemic of overprescribing? The debate on the extensive ads for prescription drugs is an old one, but some still say that the issue is not resolved. Those in favor of DTC ads say that they inform people who may […]
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FDA Blasts Cispharma in Warning Letter for Poor Injury Investigation
Latest FDA and cGMP Compliance News Any time there is an injury at a drug manufacturing plant, it is not a good situation. There is the problem of the injured employee, and then there also is the problem that the firm needs to ensure that there was no product contaminated with blood or human tissue. […]
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