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FDA Pediatric Rule

If a new drug will have significant use amongst children the FDA can order a manufacturer to conduct pediatric clinical trials prior to the marketing of the drug. Unless the manufacturer can meet an exception, pediatric safety and effectiveness data must be included not only in NDAs (New Drug Applications) and BLAs (Biologic License Application) but also in supplemental applications for new active ingredients, new indications, new dosage forms, new dosing regimens, and new routes of administration. The manufacturer is typically required to conduct at least one clinical investigation in pediatric age groups (including neonates in appropriate cases) in which a drug is anticipated to be used. There are currently several government False Claims Act investigations involving the off-label promotion of prescription pharmaceuticals for use in children, although the manufacturer had not obtained FDA approval for the pediatric population. In some cases the manufacturer had sought a pediatric indication but was refused by the FDA. See Pharmaceutical Fraud in this Glossary

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