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...
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.
Generics Firms Deterred From Continuous Manufacturing
Rutgers University professor testifies in support of bill directing the FDA to designate National Centers of Excellence in Continuous Manufacturing; other bills target generic labeling, orphan exclusivity and counterfeit devices.
Continuous Manufacturing: Cost, Lack Of Know-How Have Deterred Generic Firms, Prof Says
Rutgers University professor testifies in support of bill directing the FDA to designate National Centers of Excellence in Continuous Manufacturing; other bills target generic labeling, orphan exclusivity and counterfeit devices.