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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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.
Cancer Drugs: US FDA Looks Outside For Help On Generic Labeling Updates
Under the Oncology Center of Excellence’s Project Renewal, agency has contracted with consulting firm Deloitte to establish subject matter expert research teams that will review published literature on off-patent drugs and suggest labeling updates.
Project Renewal: US FDA's Plan To Update Generic Cancer Drug Labels Depends On NDA Holders
Agency has targeted 40 older generic chemotherapeutics for revised labeling; FDA will develop the new labeling, which will include currently accepted uses, but needs the cooperation of reference product holders who would actually have to submit the supplement.