Changing Requirements for Evaluation of Pharmacologic Agents

Pediatrics

Volumn 113, Issue 4 II, 2004, Pages 1128-1132

  Chesney, Russell W ^a,b   Christensen, Michael L ^a  

^a UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

^b LE BONHEUR CHILDREN S HOSPITAL   (United States)

Author keywords

Children in research; Drug studies; Food and Drug Administration; Institutional review board

Indexed keywords

CHILD; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG DOSAGE FORM; DRUG DOSE; DRUG EFFICACY; DRUG INDICATION; DRUG INFORMATION; DRUG LABELING; DRUG LEGISLATION; DRUG RESEARCH; DRUG SAFETY; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; HIGH RISK POPULATION; HUMAN; INFANT; MEDICATION ERROR; METHODOLOGY; NEWBORN; PEDIATRICS; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROFESSIONAL STANDARD; REVIEW;

EID: 1842482231     PISSN: 00314005     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (8)

1. Deaths due to elixir of sulfanilamide-Massengill: Report of the Secretary of Agriculture submitted to House Resolution 352 of November 18, 1937 and Senate Resolution of November 16,1937. JAMA. 1937;109:1985-1988
2. Lenz W. A study of the German outbreak of phocomelia. Lancet. 1962;2:1332
3. Taussig H. A study of the German outbreak of phocomelia. JAMA. 1962;198:1106-1114
4. Pediatric Use Supplement Rule. 21 CFR 201.57(f)(9)
5. Food and Drug Modernization Act, PL 105-115, 111 Statute 2296;1997
6. Department of Health and Human Services, Food and Drug Administration. Fed Reg. 1998;63:66632-66672
7. Best Pharmaceuticals for Children Act, PL 107-109
8. Department of Health and Human Services, Food and Drug Administration. Fed Reg. 2001;66:20589-20600