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Analyzing Pharmaceutical

As seen in: Med Device Online
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11.01.25 -- October's Most Popular Articles & Solutions

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By Erika Roberts, Mark Witcher, Sindhuri Korrapati, Analyzing Pharmaceutical
| Med Device Online
The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators. Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events.
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