Por: WPTV Nation January 11, 2023
The loophole is part of something called the 510(K) pathway. Researchers found it's led to a family tree of medical devices, recalled for potential patient harm — from IV tools in the hospital to a thermometer at home, the FDA began regulating medical devices in the '70s.Today there’s thousands upon thousands of medical devices registered to the FDA. But in 2022 the number of recalled devices were the highest in the past two... + full article
Politico USA Health December 30, 2022
The FDA’s collaboration with Biogen, the maker of a controversial Alzheimer’s drug, before it granted the product accelerated approval was “atypical” and ran afoul of the agency’s protocol for documenting interactions with drug companies, according to a joint House... + más
Alzheimer's drug approval by FDA 'rife with irregularities,' probe finds | Los Angeles Times
Probe: Alzheimer's drug approval 'rife with irregularities' | ABC News
NBC 6 South Florida USA World December 30, 2022
Adam Glanzman Bloomberg Getty Images The ’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.” The 18-month investigation by two House committees detailed... + más
FDA approves Alzheimer's drug that slowed cognitive decline in clinical trial | CNBC
ABC News USA Health December 20, 2022
WASHINGTON -- The lack of clear direction and priorities at the U.S. Food and Drug Administration's tobacco division has hampered its ability to regulate electronic cigarettes and other products, according to an expert panel assembled to examine problems at the agency.A... + más
Panel warns FDA’s beleaguered tobacco unit lacks direction | Associated Press
Panel warns FDA’s beleaguered tobacco unit lacks direction | WPLG Local 10
WPLG Local 10 USA Politics December 20, 2022
WASHINGTON – The lack of clear direction and priorities at the U.S. Food and Drug Administration's tobacco division has hampered its ability to regulate electronic cigarettes and other products, according to an expert panel assembled to examine problems at the agency.A... + más
Panel warns FDA’s beleaguered tobacco unit lacks direction | ABC News
Associated Press USA Politics December 19, 2022
WASHINGTON (AP) — The lack of clear direction and priorities at the U.S. Food and Drug Administration’s tobacco division has hampered its ability to regulate electronic cigarettes and other products, according to an expert panel assembled to examine problems at the agency.A... + más
ABC News USA Health September 30, 2022
WASHINGTON -- A much-debated drug for Lou Gehrig’s disease won U.S. approval Thursday, a long-sought victory for patients that is likely to renew questions about the scientific rigor behind government reviews of experimental medicines.Amylyx Pharmaceuticals said the Food and... + más
Highly debated Amylyx Pharmaceuticals ALS drug wins FDA approval | New York Post
ALS drug wins FDA approval despite questionable data | WPLG Local 10
ABC News USA Health September 21, 2022
The Food and Drug Administration is warning parents and teens about very unsafe social media trends, including a recent one that has begun trending online involving cooking chicken in NyQuil.The challenge -- which the FDA called “silly and unappetizing” and “very unsafe”... + más
FDA concedes delays in response to baby formula shortage | ABC News
FDA concedes delays in response to baby formula shortage | Associated Press
About iurex | Privacy Policy | Disclaimer |