Company in VA Governor’s Supplement Scandal Receives FDA Warning
The firm that is the middle of a scandal that involves the governor of Virginia’s promotion of a dietary supplement, has gotten a warning from FDA. FDA sent a warning letter to Star Scientific on December 20. FDA stated that the company is making drug claims on its website about the supplement Anatabloc. Those claims […]
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FDA cGMP Compliance News and Tips by Expertbriefings.com
Below are the original Expertbriefings.com cGMP and FDA-related stories for 2014. Be sure to review our new FDA Digest e-newsletter – learn FDA news and compliance tips, and also read our exclusive 483 and warning letter reports. FDA cGMP Compliance News and Tips March 4 – Will OTC Lipitor Win FDA Approval? Feb. 26 – […]
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FDA Approves 1st Device to Combat Migraine Headaches
FDA announced last week that it had approved the first medical device ever to relieve migraine pain. The Cerena single pulse transcranial magnetic stimulation device has been shown in a 201 patient clinical trial to be effective in relieving migraine pain for 38% of patients within two hours. And 34% were pain free within 24 […]
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FDA Cracking Down on Anti-Bacterial Soaps
FDA has stated this week that there is no evidence that antibacterial soaps help to prevent the spread of viruses and germs. There also is some clinical evidence that the soaps could cause some risks to health. FDA has issued a proposed rule that will require these manufacturers to demonstrate that the antibacterial hand soaps […]
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FDA Sends Harsh Warning Letter to Houston Cancer Doctor
FDA this week sent a tough warning letter to a doctor in Houston named Stanislaw Burzynski. He has been hailed as a hero by some of his fans, but has been derided as a snake oil salesman by many regular doctors. He long has been claiming that he has the ability in treating cancers that […]
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GSK Research Work Based on China Data Retracted
GSK stated this week that Nature Magazine has retracted one of its articles that had improper and misleading data that was tied to GSK’s research work in China. GSK recommended that the article be withdrawn, which was published three years ago. It conducted an investigation that found that much of the data in the article […]
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23andMe Still Optimistic Despite FDA Warning
In November, 23AndMe, a genetic testing company by mail that has the backing of Google, got a warning letter from FDA, which ordered the company to stop selling its $99 saliva test kit. At issue were concerns about the clinical validity of the test results. After a great deal of debate, it appeared last week […]
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FDA Gives Warning on Healthcare Defibrillators
FDA warned this week that thousands of Phillips Healthcare defibrillators may not work right during a medical emergency, due to the failure of electrical parts in the medical devices. The products are automated external defibrillators, and they are used to restart a patient’s heart. The recall first started in September 2012, and affected 700,000 devices. […]
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23AndMe To Stop Test Sales After FDA Order
23andMe, a genetic testing company, is complying with an FDA order and is going to stop selling its genetic tests after it received an FDA warning on the matter. The company stated yesterday that it will still sell ancestry related information to those who want it and also raw genetic information without any type of […]
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Will 23andMe Survive an FDA Warning Letter?
It has been only a week since FDA hammered 23andMe, a personal genetics testing service. The future of the firm is still cloudy. According to FDA, the firm has only 15 business days to show FDA that it is in compliance on its marketing of its genetic testing devices. It was accused by FDA of […]
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