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  1. Development & Approval Process (Drugs)

Off-Patent Studies under BPCA

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.