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 U.S. Food and Drug Administration said on Wednesday that it has launched a pilot program to give drugmakers faster ...
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 ...
President Obama’s nominee to lead the Food and Drug Administration recently coauthored a series of scientific papers raising concerns about the agency’s oversight of clinical trials but asked that his ...
US regulators laid out new guidelines for approving custom-made treatments for individual patients, a move that could bring ...
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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