Successes and shortcomings of the food and drug modernization act

American Journal of Hypertension

Volumn 16, Issue 10, 2003, Pages 889-891

  Flynn, Joseph T ^a,b  

^a ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^b MONTEFIORE MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMLODIPINE; AMLODIPINE PLUS BENAZEPRIL; ANTIHYPERTENSIVE AGENT; BENAZEPRIL; BISOPROLOL; CANDESARTAN; CARVEDILOL; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; ENALAPRIL; ESMOLOL; FELODIPINE; FENOLDOPAM; FOSINOPRIL; IRBESARTAN; LABETALOL; LISINOPRIL; LOSARTAN; METOPROLOL; MINOXIDIL; MOEXIPRIL; QUINAPRIL; RAMIPRIL; TIMOLOL; VALSARTAN; VERAPAMIL;

CHILD; CHILD HEALTH CARE; CLINICAL TRIAL; DRUG APPROVAL; EDITORIAL; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HUMAN; HYPERTENSION; PRIORITY JOURNAL; SIDE EFFECT;

EID: 0141451777     PISSN: 08957061     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0895-7061(03)01007-0     Document Type: Editorial

References (12)

1. Sinaiko AR: Treatment of hypertension in children. Pediatr Nephrol 1994;8:603-609.
2. Flynn JT: Pediatric use of antihypertensive medications: much more to learn. Curr Ther Res Clin Exp 2001;62:314-328.
3. Blumer JL: Off-label drug use in children. Pediatrics 1999;104:598-602.
4. Shirkey H: Therapeutic orphans. J Pediatr 1968;72:119-120.
5. von Vigier RO, Franscini LMD, Bianda NDF, Pfister R, Casaulta Aebischer C, Bianchetti MG: Antihypertensive efficacy of amlodipine in children with chronic kidney diseases. J Hum Hypertens 2001;15:387-391.
6. Flynn JT, Warnick SJ: Isradipine for the treatment of hypertension in children: a single-center experience. Pediatr Nephrol 2002;17:748-753.
7. Public Law 105-115: Food and Drug Administration Modernization Act of 1997. Adopted November 21, 1997. Available at: http://www.fda.gov/opacom/7modact.html.
8. Public Law 107-109: Best Pharmaceuticals for Children Act. Adopted January 4, 2002. Available at: http://www.fda.gov/cder/pediatric.
9. Softer B, Zhang Z, Miller K, Vogt BA, Shahinfar S: A double-blind, placebo controlled, dose response study of the effectiveness and safety of lisinopril for children with hypertension. Am J Hypertens 2003;16:795-800.
10. National High Blood Pressure Education Program Working Group: Update on the 1987 Task Force Report on High Blood Pressure in Children and Adolescents: A working group report from the National High Blood Pressure Education Program. Pediatrics 1996;98:649-658.
11. Thompson KC, Zhao Z, Mazakas JM, Beasley CA, Reed RA, Moser CL: Characterization of an extemporaneous liquid formulation of lisinopril. Am J Health Syst Pharm 2003;60:69-74.
12. Department of Health and Human Services, National Institutes of Health: List of drugs for which pediatric studies are needed. Federal Register 2003;68:2789-2790. Retrievable at http://www.gpoaccess.gov/fr/index.html.