The march toward rational therapeutics in children

Pediatric Infectious Disease Journal

Volumn 22, Issue 12, 2003, Pages 1119-1123

  Gorman, Richard L ^a,b  

^a UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^b NONE   (United States)

Author keywords

1998 Pediatric Rule; Best Pharmaceuticals for Children's Act; Pediatric trials; Pharmaceutical legislation; The Food and Drug Administration Modernization and Accountability Act

Indexed keywords

CHILD; CHILD HEALTH CARE; CONFERENCE PAPER; DRUG APPROVAL; DRUG INFORMATION; DRUG LABELING; FOOD AND DRUG ADMINISTRATION; HUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; UNITED STATES;

AGE FACTORS; CHILD; CHILD, PRESCHOOL; CLINICAL TRIALS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG APPROVAL; DRUG LABELING; DRUG UTILIZATION; FEMALE; HUMANS; INFANT; LEGISLATION, DRUG; MALE; NEEDS ASSESSMENT; PEDIATRICS; SENSITIVITY AND SPECIFICITY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0345991237     PISSN: 08913668     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.inf.0000101846.83256.5a     Document Type: Conference Paper

References (11)

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8. American Academy of Pediatrics, Committee on Drugs. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 1995;95:286-94.
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10. Department of Health and Human Services, Food and Drug Administration. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients. Fed Reg 63(No. 231): 21 CFR Parts 201, 312, 314, and 601. December 2, 1998:66632-72.
11. Department of Health and Human Services, Food and Drug Administration. Pediatric use information (b: Deferred submission; c: Waivers; d: FDA action on waiver). Fed Reg 63: 21 CFR Ch. 1 (4/1/03 ed), 314.55 b, c, d, p. 66670. December 2, 1998:104-5.