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 changes to FDA and be able to distribute the revised labeling prior to FDA’s approval. The ANDA holder would also send a notice of the supplement to the NDA holder of the referenced drug