fda
The FDA never inspected Johns Dental Laboratories during more than a decade in which it made the Anterior Growth Guidance Appliance, or “AGGA,” a dental device that has allegedly harmed patients and is now the subject of a criminal investigation. According to FDA documents obtained through the Freedom of Information Act, the agency “became aware” of the AGGA from a joint investigation by KFF Health News and CBS News in March 2023, then responded with its first-ever inspection of Johns Dental months later. That inspection found that the Indiana dental device manufacturer didn’t require all cust...
Kaiser Health News
When dermatologist Adewole “Ade” Adamson sees people spritzing sunscreen as if it’s cologne at the pool where he lives in Austin, Texas, he wants to intervene. “My wife says I shouldn’t,” he said, “even though most people rarely use enough sunscreen.” At issue is not just whether people are using enough sunscreen, but what ingredients are in it. The Food and Drug Administration’s ability to approve the chemical filters in sunscreens that are sold in countries such as Japan, South Korea, and France is hamstrung by a 1938 U.S. law that requires sunscreens to be tested on animals and classified a...
Kaiser Health News
Headlines are flying after the Department of Agriculture confirmed that the H5N1 bird flu virus has infected dairy cows around the country. Tests have detected the virus among cattle in nine states, mainly in Texas and New Mexico, and most recently in Colorado, said Nirav Shah, principal deputy director at the Centers for Disease Control and Prevention, at a May 1 event held by the Council on Foreign Relations. A menagerie of other animals have been infected by H5N1, and at least one person in Texas. But what scientists fear most is if the virus were to spread efficiently from person to person...
Kaiser Health News
A pair of heart devices linked to hundreds of injuries and at least 14 deaths has received the FDA’s most serious recall, the agency announced Monday. Related Article Patients Facing Death Are Opting for a Lifesaving Heart Device — But at What Risk? The HeartMate 3 is considered the safest mechanical heart pump of its kind, but a federal database contains more than 4,500 reports in which the medical device may have caused or contributed to a patient’s death. Read More The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by Th...
Kaiser Health News
When the FDA recently convened a committee of advisers to assess a cardiac device made by Abbott, the agency didn’t disclose that most of them had received payments from the company or conducted research it had funded — information readily available in a federal database. One member of the FDA advisory committee was linked to hundreds of payments from Abbott totaling almost $200,000, according to a database maintained by the Department of Health and Human Services. Another was connected to 100 payments totaling about $100,000 and conducted research supported by about $50,000 from Abbott. A thi...
Kaiser Health News
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