Por: The Hill Health March 01, 2023
Strict regulations on drug safety and testing make it difficult to develop new treatments for rare, obscure and deadly diseases, according to experts. As the Orphan Drug Act turns 40, advocates want Congress and the Food and Drug Administration (FDA) to be more flexible when supporting the development of treatments and cures for rare diseases. “Quality and access are the two largest challenges for the next few years,” Thomas Crawford, a... + 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
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
WPLG Local 10 USA Politics 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.The Food and Drug Administration approved... + más
ALS drug wins FDA approval despite questionable data | ABC News
Associated Press USA Science September 30, 2022
WASHINGTON (AP) — 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.The Food and Drug Administration... + más
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