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.
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Takeda’s TAK-721 is back, ARS Pharma will be back soon to appeal neffy complete response letter, US FDA’s Project Renewal brings Temodar labeling in current day, and more highlights from the Pink Sheet’s US FDA Performance Tracker.
The FDA could partner with industry, academia and advocacy groups to speed development of novel treatments for cancers that are not commercially viable.
Oncology Center of Excellence is reviewing a research report on fluorouracil, and will next look to update cisplatin's label, but eventually must convince the reference product sponsor to submit the changes.