FDA Proposes Unilateral Generic Drug Label Changes, Signaling End To Liability Shield
This article was originally published in The Pink Sheet Daily
FDA proposed rule would allow ANDA holders to unilaterally make label changes prior to FDA’s approval; NDA and other ANDA holders would have 30 days to revise their labels once FDA approves the change.
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Label updates for older generics are still planned, Commissioner Gottlieb says, but will depend more on sponsor collaboration as well as additional resources and authorities from Congress.
FDA must place antimicrobial breakpoints that usually appear in labeling on a website so they can be more regularly updated. CDER Director Woodcock said that could become a precedent for other electronic labeling changes.
Former Sidley Austin partner brings a wealth of experience in drug product liability litigation and federal preemption. She replaces agency veteran Elizabeth Dickinson, who will stay on as senior deputy to the chief counsel.