FDA labeling status of pediatric medications

Clinical Pediatrics

Volumn 45, Issue 1, 2006, Pages 75-77

  Yoon, Esther Y ^a,c   Davis, Matthew M ^a,b   El Essawi, Heba ^a   Cabana, Michael D ^a  

^a UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^b UNIVERSITY OF MICHIGAN   (United States)

^c UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GABAPENTIN;

ARTICLE; CHILD CARE; DRUG LABELING; EXPERIENCE; FOOD AND DRUG ADMINISTRATION; INTOXICATION; MEDICATION ERROR; PEDIATRICS; PRESCRIPTION; PRIVATE PRACTICE; SEIZURE;

CHILD; CHILD, PRESCHOOL; CROSS-SECTIONAL STUDIES; DRUG LABELING; FEMALE; HUMANS; INFANT; MALE; PEDIATRICS; PHARMACEUTICAL PREPARATIONS; PRESCRIPTIONS, DRUG; SENSITIVITY AND SPECIFICITY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33644842256     PISSN: 00099228     EISSN: None     Source Type: Journal    
DOI: 10.1177/000992280604500112     Document Type: Article

References (8)

1. Wilson JT. An update on the therapeutic orphan. Pediatrics. 1999;104 (Suppl):585-590.
2. Blumer JL. Off-label uses of drugs in children. Pediatrics. 1999;104(Suppl):598-602.
3. Committee on Drugs, American Academy of Pediatrics. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics. 1995;95:286-294.
4. Steinbrook R. Testing medications in children. N Engl J Med. 2002;347:1462-1470.
5. Committee on Drugs, American Academy of Pediatrics. Unapproved uses of approved drugs: the physician, the package insert and the Food and Drug Administration: subject review. Pediatrics. 1996;98:143-145.
6. Meadows M. Drug research and children. Available at: http://www.fda.gov/ fdac/features/2003/103_drugs.html. Accessed on September 11, 2003.
7. Thomson Micromedex Healthcare Series, Volume 121. Available at: http://micromedex.med.umich.edu/mdxcgi/mdxhtml.exe?&tmpl=mdxhome.tml& SCRNAME=mdxhome&CTL=E:\mdx \mdxcgi\megat.sys. Accessed on November 12, 2004.
8. Roberts R, Rodriguez W, Murphy D, Crescenzi T. Pediatric drug labeling: improving the safety and efficacy of pediatric therapies. JAMA. 2003;290:905-911.