Remove a Wart, Burn Down Your House?
FDA reported last week that more than a dozen US consumers have started fires in their homes with a wart removal product. The products work by freezing the warts, but they contain a mix of dimethyl ether and propane. The warning labels note that they should not be kept near fire or other heat sources. […]
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MRC Tells Congress – Do Not Pass Legislation, Wait for FDASIA Report
Just as FDA has said, the mHealth Regulatory Coalition (MRC) has approved a new policy that urges the US Congress to not pass any legislation that regulates health information technology, which includes mHealth. MRC states that lawmakers should instead wait for a required FDASIA report to come out that will detail risk based regulatory rules […]
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FDA Warns that Acetaminophen Dosages Higher Than 325 Mg May Cause Liver Damage
If you have pain after a recent surgery, your doctor probably has given you Vicodin or Percocet. When you arrive home, you may decide that you still are in pain and you still decide to take Tylenol on top of it. You may not know it, but you may be doing liver damage. Acetaminophen is […]
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FDA: OTC Laxatives Can Kill
You may to reconsider taking OTC laxatives, especially day after day. A new FDA press release reports that OTC laxatives are dangerous if consumers fail to follow the warnings and instructions. FDA has noted this month that it has gotten reports of as many as 13 deaths related to the use of laxatives. There also […]
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eTMF Use Is Still Not Nearly As High As It Could Be
The use of eTMFs, or electronic Trial Master Files, is going up, according to a recent survey by NextDocs, but more than 50% of people who responded to the survey said they are still doing much of their clinical trials on paper. This survey was taken in the beginning of 2013, polling about 50 life […]
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How Dangerous Are E-Cigarettes?
As of today, the electronic cigarette market is a bit of the Wild West. At this time, the makers of these products are able to make therapeutic claims because there has been no FDA approval of any of these products yet. Some experts claim that tobacco companies are taking advantage of the unregulated environment because […]
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Wanted by FDA – Gum Chewing Tester
This is a story you don’t see every day out of the FDA. The agency currently is seeking a small business to supply FDA with a tester of chewing gum. No matter that the announcement sounds rather frivolous, this search is completely serious, and actually, is a growing need for FDA. Pharmaceuticals that are used […]
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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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