Understanding Labeling Flashcards
Why is the label important?
The approved label is a summary for the safe and effective use of the drug and the basis for the claims that can be made about the product.
How is consistent labeling content maintained worldwide?
The company position on labeling content is documented in the Core Data Sheet (CDS), which is distributed to all affiliates for implementation into the local label.
What are the two major components of the CDS?
The CDS describes the essential safety profile and the maximum efficacy claims based on all of the available scientific data, including clinical trials.
Who leads the labeling efforts?
PDRL leads the Labeling Subteam (LST) and the CDS work. PDR-PM partners, as members of the LST, lead EU and US efforts; the PDR IPP as a member of the LST leads ROW activities.
When do labeling activities start?
Activities begin as early as Phase I for new molecules and new indications. Safety updates are tied to the safety decision that a label update is required.
