Reports mentioning Food and Drug Administration
Futurist Max Tegmark has raised a pointed question regarding the disparity in regulatory frameworks between artificial intelligence (AI) and common food items in the United States, specifically using sandwiches as a point of comparison.
The U.S. Food and Drug Administration (FDA) is anticipated to render a decision regarding the potential approval of the inaugural messenger RNA (mRNA) influenza vaccine. This forthcoming decision represents a pivotal moment in public health, potentially ushering in a new…
The Food and Drug Administration (FDA) granted breakthrough designation to two generative AI devices designed to interpret chest X-rays and draft radiology reports on March 14, 2024. These systems represent an advancement beyond traditional machine learning, which has analyzed medical…
Regenxbio announced on Wednesday that it will seek accelerated approval for its gene therapy targeting Duchenne muscular dystrophy. This decision follows a statement made by the company just one month prior, indicating that regulatory bodies required an additional trial…
Pathway Labs received Food and Drug Administration (FDA) clearance this month for EchoNext, an artificial intelligence model designed to detect seven forms of structural heart disease from electrocardiograms (EKGs). Developed by researchers at New York-Presbyterian Hospital and Columbia University, EchoNext…
The Food and Drug Administration (FDA) will reconsider approving Regenxbio's experimental gene therapy for mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, a rare and fatal childhood brain disorder.
A panel of advisers to the Food and Drug Administration endorsed Moderna's seasonal mRNA flu vaccine on Thursday, marking a significant step after the vaccine faced controversy earlier this year when a top agency official initially refused to review it.