FDA Plans To Overhaul Medical Device Approval Process
Since 1976, the FDA has been using the 510k process to approve most medical devices. This pathway once was the exception to the rule has now become the bypass standard. Facing growing pressure from the public, the agency says it will now look to overhaul the system but insists it still works. About the 510k
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FDA Recalls All Amlodipine/Valsartan Medications Due to Cancer Risk
The FDA has recalled all lots of amlodipine/valsartan combination tablets and amlodipine/valsartan/hydrochlorothiazide combination tablets in the United States. The manufacturer found more n-nitroso-diethylamine (NDEA) in the medication. NDEA is a probable human carcinogen. This is the fourth recall stemming from the discovery of the cancer-causing agent starting in May. About Valsartan Manufactured by Major Pharamascetucials,
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Study Shows Age Effects Mesothelioma Tumors Growth
Curtin University in Australia completed a study in an attempt to understand why some malignant mesothelioma victims succumb so much faster than others. Researchers discovered that certain immune cells, macrophages, actually work against the body’s ability to fight off cancerous tumors in elderly laboratory animals. The study postulates that the same dynamic is likely true
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Holding Manufacturers Responsible for Kia Fires
Consumer groups are pressing the National Highway Traffic Safety Administration to investigate complaints of spontaneous Kia fires. These fires are unrelated to crashes. The group filed a formal petition asking NHTSA to research four models all from the years 2011-2014. The spontaneous fires have injured at least six people. However, there are nearly 200 complaints
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Jehovah's Witness Punished For Being Sexually Abused
Now, a woman in her 20s, Stacey* remembers being 17 and riding in the truck with her father. She felt like her father could protect her against anything. Therefore, she reached out to him and told him that a couple in their church had been sexually abusing her for months starting when she was 15.
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FDA Has Linked Romaine Recall to California
The FDA Commissioner Scott Gottlieb announced on Twitter that the agency traced the romaine recall to the West Coast. The CDC still warns to not eat any romaine lettuce since it still hasn’t discovered the source of the contamination. About E.Coli E.Coli is bacteria that normally live in the intestines of healthy people and animals. While
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Michigan Judge Suspended Over Sexual Harassment Allegations
A Chief Judge has suspended another Michigan judge after sexual harassment allegations surfaced. The decision also barred him from the court’s property but can make decisions in some pending cases. The suspension order says Newaygo County is investigating the claim, yet the judge denies the sexual harassment allegations. About Sexual Harassment Federal law prohibits sexual
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Cruise Ship Deck Burns Passenger's Feet
A Celebrity cruise ship deck burns a passenger’s feet so badly that the 66-year-old man suffered from neuropathy of his feet. Neuropathy is the dysfunction of one or more peripheral nerves, typically causing numbness or weakness. Once afflicted, the disease can last a lifetime. Cruise Ship Negligence Some accidents are just that, accidental, and no
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CDC Says All Romaine Is Unsafe
Make sure to be cautious of any salad at Thanksgiving this week. The CDC says to throw away all romaine lettuce after the vegetable made 32 people sick. Doctors also had to hospitalize 13 during this multistate E. coli outbreak. About E.Coli E.Coli is bacteria that normally live in the intestines of healthy people and animals. While most
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Study Reveals Deaths of Teen Gadolinium Retention Patients
JAMA has published a study examining the effects of gadolinium retention in the pediatric brain. The study revealed the death of three teen gadolinium retention patients who participated in the study. Yet, many in the medical community still deny the existence of the disease that injures so many. About Gadolinium Gadolinium is a chemical element carrying
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