The guidance encourages the use of Bayesian statistics in drug trials. Instead of starting from scratch and only adding new ...
The proposed recommendations are intended to safely expedite approvals of promising therapies for multiple myeloma, but one expert is skeptical about the likelihood of industry compliance.
Opinion: The Food and Drug Administration's updated guidance on wellness devices will help ensure that products are appropriately positioned in the market—while staying away from unsupported, ...
"The FDA rejected Moderna's application for filing because the company refused to follow very clear FDA guidance from 2024 to ...
FDA proposes MRD-negative and complete response endpoints to fast-track multiple myeloma drug approvals, pushing deeper molecular results over ORR.
WASHINGTON, D.C., USA — The U.S. Food and Drug Administration on Wednesday released 10 new guidelines for drug manufacturers to follow when using artificial intelligence to develop new treatments. The ...
The FDA approved changes to the labels for six menopausal hormone therapy products in a move the agency said clarifies risk ...
Qualifying for *** COVID-19 vaccine really depends on your age, health, and insurance coverage. And now most people don't meet the guidelines. On Wednesday, the Food and Drug Administration approved ...
The Food and Drug Administration (FDA) announced Thursday it will not enforce federal regulations regarding “false or ...
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