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.
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.
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