FDA Proposes Unilateral Generic Drug Label Changes, Signaling End To Liability Shield

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.

FDA is putting pressure on generic manufacturers to play a more proactive role in postmarketing surveillance in issuing a proposed rule allowing them to unilaterally change their labeling to include new safety information.

Under the proposal, ANDA holders would submit a supplemental application – a “changes being effected” (CBE) supplement – for labeling...

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