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

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Post-Marketing Regulation & Studies

More from Product Reviews

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Tepezza, Amgen's treatment for moderate to severe thyroid eye disease.

CAR-T REMS Removal Should Boost Access, But Long-Term Follow-Up, Black Box Remain

 

The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US