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 GSK recommended that the article be withdrawn, which was published three years ago.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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Major Job Cuts At Merck in Ireland, Forest Labs
Merck announced this week that it plans to close a plant in Ireland at the end of 2017, which is going to cut almost 600 jobs. The closure of the plant in Swords, Co Dublin is because of the review of the company’s manufacturing needs around the world indicated that the plant was no longer […]
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Main Wockhardt Drug Plant in India Banned by FDA
Wockhardt Ltd. is now banned from selling several drugs in the US from another factor in India, after FDA inspectors added it to a restricted list. This caused the company’s stock to drop 14%. The Wockhardt facility in Aurangabad, which is its highest revenue producer, was added to FDA’s red list last week. This means […]
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DNA Test Maker Hit With Nasty Warning Letter
FDA last week ordered the DNA testing firm 23andMe to cease selling its OTC generic DNA test, stating that it is being sold without FDA approval to diagnose diseases. The DNA test, which has been heavily marketed in recent months, has a kit to sample your saliva, and the firm promises that it will offer […]
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