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 ...
As reported in our August 7, 2024, blog item, the U.S. Food and Drug Administration (FDA) announced on August 1, 2024, that it will hold a public meeting on September 25, 2024, on the development of ...
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 ...
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 ...
Rapid scientific advances are accelerating the development of medical innovations, from personalized treatments to curative gene therapies and advanced diagnostic tools. But significant policy and ...
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 ...
With states like California, Illinois, and New York questioning the safety of certain food additives and some other chemicals used in food, the public is wondering if a food is safe to eat if it ...
Rapid scientific advances are accelerating the development of medical innovations, from personalized treatments to curative gene therapies and advanced diagnostic tools. But significant policy and ...
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