FDA has released a white paper outlining a potential regulatory framework for software as a medical device (SaMD) that leverages artificial intelligence (AI) or machine learning (ML). The white paper ...
The FDA has documented the steps leading up to the approval of Biogen’s Alzheimer’s disease drug Aduhelm, revealing how the mixed evidence on the controversial therapy divided its staff. In its ...
The FDA chief has called into question whether the agency will approve and authorize the COVID-19 vaccine for winter. In August 2024, the U.S. Food and Drug Administration approved the updated mRNA ...
US regulators laid out new guidelines for approving custom-made treatments for individual patients, a move that could bring ...
An FDA advisory panel will discuss in April the efficacy of a popular over-the-counter decongestant, phenylephrine, amid concerns the oral drug does not work. The agency said the committee will ...
CHICAGO – Two new studies find shortfalls in the Food and Drug Administration’s approval process for heart devices such as pacemakers and stents. Safety targets often weren’t clearly spelled out in ...
President Donald Trump's choice to lead the Food and Drug Administration (FDA) flipped a question about vaccine processes around on a top Democratic senator during his confirmation hearing on Thursday ...
WASHINGTON — Seeking ways to ensure that pet food is safe, a Senate subcommittee plans to question Food and Drug Administration officials as soon as Thursday about their response to the contamination ...
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