Pediatric generic labeling guidance called off
Executive Summary
FDA no longer plans to issue guidance on labeling for generic drugs when the reference product has protected pediatric labeling. "Since there is little or no action required from the ANDA sponsor on creation of these labeling drafts, a guidance would not be appropriate," agency says. Best Pharmaceuticals for Children Act permits approval of generics without innovator pediatric labeling (1"The Pink Sheet" Jan. 14, 2002, p. 5)...