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

 
• By Sue Sutter

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.”

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More from Post-Marketing Regulation & Studies

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 
• By Sarah Karlin-Smith

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Global Regulators Consider Extending Pilot On Post-Approval CMC Changes After Positive Findings

 
• By Eliza Slawther

Regulatory authorities from multiple regions are considering extending a pilot project related to collaborative assessments of post-approval chemistry, manufacturing and controls changes, with a focus on the supply of critical medicines.

Pharma Industry Wants Easier Access To England’s Revamped NHS Data Sharing System

 
• By Eliza Slawther

The pharmaceutical industry was not sufficiently involved in designing updates to England’s health data infrastructure, leading to a “misalignment” between company needs and what is currently being delivered, according to the results of a survey by the Association of the British Pharmaceutical Industry.

US FDA In ‘First Stages’ Of Reconsidering Black Box For Antipsychotics

 
• By Ramsey Baghdadi

Patient advocates and sponsors want the US to reconsider a 20-year-old class warning against the use of antipsychotics in patients with dementia. The agency is weighing the issue, but also defending the current labels of newer agents.

More from Product Reviews

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 
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US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
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New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.