FDA Releases Ugly Novartis 483 for Lincoln NE Plant
Updated Daily – Read our latest FDA, cGMP Compliance News Novartis decided to give it up last week and announced that it was going to shrink drug manufacturing operations at its Lincoln, NE plant. They now only plan to make powder and solid products there, which include Excedrin headache pills, Theraflu, and Sentinel, which is […]
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FDA Allows Access to Plan B to 15 Year Olds
Updated Daily – Read our latest FDA, cGMP Compliance News A year after the agency was mandated by the Obama administration to reject its intent to make the Plan B contraceptive available to all women of all ages with no prescription required, FDA has now approved it for women 15 and older. Until this time, […]
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FDA and Allergan Warn About Fake Botox From Overseas
Updated Daily – Read our latest FDA, cGMP Compliance News There is a new ‘wrinkle’ in the fight in the US on counterfeit drugs. There is now a fake version of Botox that is being marketed in the US by Internet and fax. This time, the packaging on the counterfeit drug looks identical to the […]
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More Counterfeit Drugs Pop Up – What to Do?
Updated Daily – Read our latest FDA, cGMP Compliance News Congress is currently mulling over a bill to provide better security to the drug supply, but we are seeing reports of still more counterfeit drugs coming onto the market. The latest is regarding an FDA alert about fake Botox, with the labels on the vials […]
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Senate Bill Gains Major Support to Increase FDA Muscle on Drug Compounders
Updated Daily – Read our latest FDA, cGMP Compliance News Not long after a nationwide fungal meningitis outbreak that was found to have been caused by a drug compounding pharmacy, 35 US senators have put together draft legislation that would boost FDA oversight of compounders and also would have a list of strict requirements for […]
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Hooters and Fishing Trips for Docs – Has Novartis Violated Corporate Integrity Agreement?
Updated Daily – Read our latest FDA, cGMP Compliance News The last week has not been a good one for Novartis. Now federal authorities have filed another lawsuit that charges Novartis with giving kickbacks to increase the issuance of prescriptions. This allegedly caused Medicare and Medicaid to pay for drugs based upon false claims. […]
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FDA Raids Cancer Clinic, Confiscates Laetrile
Updated Daily – Read our latest FDA, cGMP Compliance News FDA shut down a cancer clinic in Tulsa, OK this week, after federal agents appeared at Camelot Cancer Care in the southern part of Tulsa and issued a search warrant. It appears that FDA was there because the cancer center was using Laetrile which is […]
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Salesman for Fake Avastin Pleads Guilty to Felony
Updated Daily – Read our latest FDA, cGMP Compliance News There is yet more fallout from the fake Avastin problem from 2012. This time, a former sales representative for a pharmacy in Canada pleaded guilty for selling cancer drugs that were both misbranded and unapproved. The salesman’s name is Paul Bottomley and he faces 3 […]
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FDA Counterfeit Device Detector Targets Fake Malaria Drugs
Updated Daily – Read our latest FDA, cGMP Compliance News A new, portable device designed by FDA is going to be a new, powerful weapon for efforts to wipe out malaria around the world. In a few years, it is possible that the new device will be able to easily detect worthless counterfeit drugs that […]
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Monkey Abuse Scandal – Harvard Shutting Down Primate Research Center
Updated Daily – Read our latest FDA, cGMP Compliance News Harvard Medical School is closing the New England Primate Research Center in the next two years because it is having trouble obtaining research funding. A federal grant from NIH is not going to be renewed, either. This decision has come after Harvard began to work […]
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