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

20 Dec 2022

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

The US Food and Drug Administration’s first experience with updating the approved indications for an older chemotherapy drug has caused it to reset the timetable for future labeling revisions under the Oncology Center of Excellence’s “Project Renewal.”

With its first labeling update now behind it, OCE is targeting one to two labeling updates annually, rather than the...