FDA Investigating Risks of Testosterone Therapy
FDA announced at the end of last week that it is going to investigate risks of heart disease and death that may be caused in some cases by testosterone therapy. This is a move by FDA that is being prompted by two clinical studies that have raised some questions about the health risks of using […]
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FDA – Aleve Safer For Heart Than Other Drugs
FDA state this week that the Aleve pain reliever could be safer for your heart than many other types of anti-inflammatory drugs that millions of Americans take every day. According to an FDA review that was posted on the FDA website this week, naproxen could have a lower heart attack risk as well as stroke, […]
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Evidence Quality That FDA Uses to Approve Drugs Varies Widely
FDA has been trying to approve drugs faster and to also show more flexibility in the endorsement of therapies for many types of serious diseases. But an interesting wrinkle is starting to emerge, according to a recent Forbes report. There is a lot of variety in the quality of the evidence that is being used […]
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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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