The Lack of Data on Off-Label use of Noninvasive Positive Pressure Ventilation in Children

Teague WG . Pediatric application of non-invasive ventilation. Respir Care 1997; 42(4):414–423.

Hill NS . Noninvasive ventilation. Does it work, for whom, and how? Am Rev Respir Dis 1993;147(4):1050–1055.

BiPAP service manual: warnings, cautions and notes. Feb, 2000: Chap 1. Pg 1. Respironics Corp; Pittsburgh PA.

Dept of Health and Human Services. FDA 1988 Code of Federal Regulations, Title 21. Parts 800–895.

VPAP Clinical manual: warnings, cautions. Jul, 1999: Pg 4. Resmed Corp; San Diego CA.

Federal Registry Dept of Health and Human Resources. Requiring manufacturers to asses the safety and effectiveness of new drugs and biological products in pediatric patients; Aug, 1997.

Kauffman PE . Status of drug approval pro-cess and regulation of medications for children. Curr Opin Pediatr 1995;7(2):195–198.

Torres A. The use of Food and Drug Administration-approved medications for unlabeled (off-label) use: the legal and ethical implications. Arch Dermatol 1994;130(1):32–36.

Food and Drug Administration Modernization Act—1999 FDA Reg 21, CFR Part 99.