All Draft guidance articles
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Industry newsFDA releases new draft guidance on assessing artificial intelligence data
The US Food and Drug Administration (FDA) has released new draft guidance which provides a risk-based credibility framework that can be used for assessing artificial intelligence (AI) data in the drug product lifecycle.
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Industry newsEMA proposes novel method to assess CKD therapy efficacy
Glomerular filtration rate slope can be used as a surragate end point to assess clinical benefit for treatments in CKD in some trial settings.