Related Posts:
Caution - Teeth Whiteners Can Reduce Enamel Strength
Mercury-Containing Dental Fillings - Health and Environmental Concerns
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Showing posts with label manufacture. Show all posts
Showing posts with label manufacture. Show all posts
Wednesday, May 13, 2009
FDA Expected To Rule On Mercury Dental Amalgams
I'm so glad that I don't have mercury fillings in my mouth anymore. Unfortunately, I've got a mouthful of crowns, and precious little left of my natural teeth.
I ran across this press release, and thought you'd be happy to know that the FDA is expected to rule on mercury-containing dental amalgams, "Resolution to Study Phase Out of Mercury Tooth Dental Fillings Receives 16% of Vote at Danaher Shareholder Meeting." The press release states, "Some-time in late July, the Food and Drug Administration is expected to rule on the use of mercury amalgam. The Consumers for Dental Choice won a 10-year battle with the FDA to comply with the law and set a date to classify mercury amalgam."
Monday, March 9, 2009
FDA - Focus On Opioid Manufacturer REMS FDAAA
Updated September 15, 2016
The original post didn't age well (broken links).
You might also be interested in:
Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids (FDA.gov)
- - original post follows below - -
If you're involved in or follow opioid manufacturing, you'll want to follow the FDA's focus on manufacturers of certain opioid drug products. FDA indicates that these drugs will be required to have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drugs continue to outweigh the risks. The affected opioid drugs include brand name and generic products and are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. The FDA has authority to require a REMS under the Food and Drug Administration Amendments Act of 2007 (FDAAA) when necessary to ensure that the benefits of a drug outweigh the risks. You can expect to hear more about this over the next several months from the FDA.
More FDA Information About This Topic:
Transcript for FDA's Media Briefing on the Safe Use of Opioids
February 9, 2009 [pdf 52 KF] Audio [5.09 MB MP3]
FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs
Previous Posts:
Opiates Can Kill Kids!
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Tuesday, January 13, 2009
Say Maaah - Goats Make Anti-Clot Drug
This could be the shape of things to come, genetically engineered animals turned drug-making machines. This LA Times article, New old-fashioned drug makers: goats, reports that genetically engineered goats produce a human protein that is extracted and turned into a medicine to fight strokes, pulmonary embolisms and other dangerous conditions caused by blood clots. A panel of the Food and Drug Administration voted overwhelmingly that the drug -- called ATryn -- is safe and effective. The FDA is expected to make a final ruling soon. If approved, this would be unprecedented, the drug would be the first from a genetically engineered animal to be approved in the United States. If ATryn gets approved, you can expect to see more milk produced by genetically engineered rabbits and cows for future lines of drugs to treat hemophilia, respiratory disease and swollen tissues. By the way, do goats really say maaah?!
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