US FDA Still Seeking Sponsor Cooperation For Oncology Label Updates
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.
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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.
Capecitabine’s existing indications were revised and new indications added, reflecting uses that long have been considered standard of care; however, the cancer drug's label had been frozen in time since the approval of generics.
The US FDA commissioner called for enhancements to postmarketing data collection and analysis for generic drugs.