Dear all,
The FDA has published a draft guidance document titled "Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products" (https://www.fda.gov/media/184830/download).
This document presents a seven-step framework for assessing the risks associated with AI models in drug and biological product development. It provides valuable insights into best practices for the responsible application of AI in future research and development.
Best regards.
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Sudip Das, MPharm, PhD
Distinguished Faculty, Butler University
Professor of Pharmaceutics & Drug Delivery
4600 Sunset Avenue, Indianapolis, IN 46208-3485
E-mail:
[email protected]Webpage:
https://research.butler.edu/nanomedicine/LinkedIn:
http://www.linkedin.com/in/sudipkdasDisclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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