Ensuring Safe and Effective Medications for Children

JAMA

Volumn 290, Issue 7, 2003, Pages 950-951

  Budetti, Peter P ^a  

^a UNIVERSITY OF OKLAHOMA HEALTH SCIENCES CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

ADOLESCENT; CHILD; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG MARKETING; DRUG SAFETY; EDITORIAL; FOOD AND DRUG ADMINISTRATION; HUMAN; INFANT; NEWBORN; PEDIATRICS; PRESCRIPTION; PRIORITY JOURNAL; SIDE EFFECT; DRUG LABELING; DRUG THERAPY; LEGAL ASPECT; NOTE; STANDARD; UNITED STATES;

CHILD; DRUG LABELING; DRUG THERAPY; HUMANS; PEDIATRICS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0041695198     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.290.7.950     Document Type: Editorial

References (15)

1. Roberts R, Rodriguez W, Murphy D, Crescenzi T. Pediatric drug labeling: improving the safety and efficacy of pediatric therapies. JAMA. 2003;290:905-911.
2. Food, Drug and Cosmetic Act, 21 USCS §301 (1938), amended Pub L No. 107-281 (2002).
3. Washington Legal Foundation v Henney, 202 F3d 331 (DC Cir 2000).
4. American Academy of Pediatrics, Committee on Drugs. Uses of drugs not described in the package insert (off-label uses). Pediatrics. 2002;110:181-183.
5. Steinbrook R. Testing medications in children. N Engl J Med. 2002;347:1462-1470.
6. Choonara I, Conroy S. Unlicensed and off-label drug use in children: implications for safety. Drug Saf. 2002;25:1-5.
7. Food and Drug Administration Modernization Act, Pub L No. 105-115, 111 Stat 2296 (1997).
8. Best Pharmaceuticals for Children Act, Pub L No. 107-109, 115 Stat 1408 (2002).
9. Specific requirements on content and format of labeling for human prescription drugs, 44 Federal Register 37434 (1979).
10. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients: final rule, 63 Federal Register 66632 (1998).
11. Association of American Physicians and Surgeons Inc v US Food and Drug Administration, 226 F Supp 2d 204 (DC Cir 2002).
12. US Department of Health and Human Services, US Food and Drug Administration. Pediatric Exclusivity Provision: January 2001 Status Report to the Congress. Rockville, Md: US Dept of Health and Human Services; 2001.
13. Zimmerman R. Drug makers find a windfall testing adult drugs on kids. Wall Street Journal. February 5, 2001.
14. Pediatric Research Equity Act of 2003, S. 650, 108th Congress.
15. S. Rep. No. 108-084. Available at: http://thomas.loc.gov/cgi-bin/cpquery. Accessibility verified July 30, 2003.