Business · 24/04/2002

FDA Issues Advanced Notice of Proposed Rulemaking to Update Pediatric Studies and Labeling for Human Drugs and Biologics

The FDA is seeking public comments on updating the 1998 pediatric rule to ensure timely pediatric studies and adequate pediatric labeling for human drugs and biologics used in treating children, building on the Best Pharmaceuticals for Children Act (BPCA) signed into law in 2002.