Obtaining Timely Pediatric Studies of and Adequate Pediatric Labelingfor Human Drugs and Biologics

Resumen

Given the present authorities contained in the Best Pharmaceuticals for Children Act (BPCA), which was signed into law January 2002, the Food and Drug Administration (FDA) is issuing this advanced notice of proposed rulemaking (ANPRM) to solicit comments on the most appropriate ways to update the 1998 "pediatric rule" so that it can most effectively address FDA's interest in timely pediatric studies of and adequate pediatric labeling for human drugs and biological products that are used or will be used in the treatment of children. FDA is interested in what mechanisms, if any, may be necessary to augment the programs described in the BPCA and what present authorities, if any, have not proven effective, are now redundant, or need to be updated because of the BPCA.