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 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 ...
The U.S. Food and Drug Administration said on Wednesday that it has launched a pilot program to give drugmakers faster ...
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