Weight-loss pills that harness the same mechanism as the wildly popular drugs Wegovy and Ozempic are coming to the U.S. On Monday Novo Nordisk announced that the U.S. Food and Drug Administration ...
Balasegaram is executive director of the Global Antibiotic Research & Development Partnership. No matter how carefully we use the antibiotics we have, drug resistant infections will continue to gain ...
The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions. The agency said the policy change aims to enable the use ...
The FDA has eliminated a key barrier to the use of real-world evidence in certain medical device applications. Under new guidance issued Dec. 15, the agency said it will accept real-world evidence ...
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