Project Renewal: US FDA's Plan To Update Generic Cancer Drug Labels Depends On NDA Holders
Executive Summary
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.
You may also be interested in...
Office Of New Drugs Reorg Is Bigger Than Expected: US FDA Adds 11 Review Divisions
Long-planned OND 'modernization' to better match workflow, allow more time with stakeholders includes proposed restructuring that would boost number of offices overseeing review operations (adding four for a total of nine) and drug review divisions (adding 11 for a total of 30).
US FDA's Label Updating Effort Needs Legislation To Impact Generics
Generic labels can't easily be changed if reference product is withdrawn, meaning legislative fix is needed to add current recommendations to outdated labels.
US FDA Looks To Proactively Update Old Generic Drug Labels Under Pilot
Concept mentioned during Gottlieb’s 'star' turn at Davos may sound similar to now-withdrawn generic labeling rule, but actually appears based on a proposal from the Friends of Cancer Research to get current clinical guidelines reflected on labels.