FDA Oncology Center Now Aiming For One To Two Labeling Updates Annually Under ‘Project Renewal’

First several years of OCE initiative for older cancer drugs have been spent establishing an objective, repeatable and collaborative approach for updating indications and other label information; agency continues to streamline the ‘complicated’ regulatory process with sponsors.

First in line
Capecitabine was moved to head of the line for labeling changes under FDA's Project Renewal. • Source: Shutterstock

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