The FDA now accepts RWE for device submissions without needing identifiable patient data, facilitating the use of large, de-identified databases. This change addresses previous limitations that ...
The FDA announced that it removed a limitation on the use of real-world evidence (RWE) in drug and device application reviews ...
Claims that Lyme disease was developed as a military bioweapon and escaped from a government lab are flatly contradicted by decades of scientific evidence -- despite what federal regulators have ...
Commissioner Marty Makary on Monday denied recent reports suggesting plans for his agency to add a black box warning onto ...
The Food and Drug Administration (FDA) called on food industry companies to strengthen their recall compliance practices, ...
Officials said they were considering such a move last week, but the plan was widely condemned by health experts.
The retailers, including Target, Walmart, The Albertsons Companies and The Kroger Co., sold some of the contaminated baby ...
The FDA sent warning letters after inspectors found ByHeart baby formula for sale weeks after a botulism-linked recall.
U.S. lawsuits against Novo Nordisk and Eli Lilly alleging patients taking weight loss drugs lost some or all of their ...
FDA sends warning letters to retailers for selling recalled baby formula linked to botulism outbreak
The US Food and Drug Administration sent warning letters to Target, Walmart, Kroger and Albertsons after some of the stores ...
Sunscreens in the United States might soon be able to include a new ingredient.
Johnson & Johnson, which did not apply for the national priority voucher, was granted the ticket based on results from a ...
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