Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft
FDA Law Blog: Biosimilars
FEBRUARY 13, 2025
FDA provides definitions for the three datasets. Although data scientists sometimes refer to the tuning dataset as the validation dataset, FDA encourages using terminology consistent with the Agencys Artificial Intelligence Glossary. Update practices and training of end users also need to be addressed.
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