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By Erika Roberts, ELR Lab Services LLC | 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. | |
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By Julio G. Martinez-Clark, bioaccess | Brazil is experiencing a regulatory revolution that is fundamentally transforming its medical device clinical trial landscape. | |
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By Andrew Walsh, Thomas Altmann, Joshua Anthes, et al. | A cleaning validation professional must know how many process performance qualification runs are necessary. Here's how to go about demonstrating this with a high degree of assurance while minimizing the number of qualification runs. | |
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