Off-Patent Studies under BPCA

BPCA provides a mechanism for the National Institutes of Health (NIH) to identify drugs no longer under patent that need to be studied in children due to a lack of dosing, safety or efficacy data.  FDA works with the NIH to ensure that data from the clinical studies is considered for labeling modification.

• Off-Patent Written Requests Issued
  List of approved active moieties that have appeared on the NIH Priority List and for which an Off-Patent Written Request was issued. 
• List of Drugs for Which Pediatric Studies Are Needed
  Pediatric study of off-patent drugs under BPCA.  The requirements for these lists changed in 2007 under the FDA Amendments Act.  More recent lists may be found at  Best Pharmaceuticals for Children Act Priority Lists (NIH) 
• NIH Funded Pediatric Labeling Changes
• For more information, see Best Pharmaceuticals for Children Act (BPCA)