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
The manufacturer should, in addition to stating whether the modification will be implemented manually or automatically, include details such as: End user actions needed, if any to implement the change, Timing of implementation, Extent of implementation in the install base, and Include references to expected labeling changes.
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