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Volumn 110, Issue 1 I, 2002, Pages 181-183

Uses of drugs not described in the package insert (off-label uses)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

EID: 0036305225     PISSN: 00314005     EISSN: None     Source Type: Journal    
DOI: 10.1542/peds.110.1.181     Document Type: Review
Times cited : (118)

References (10)
  • 3
    • 0009692308 scopus 로고    scopus 로고
    • Drug Amendments of 1962. Part A: Amendments to assure safety, effectiveness, and reliability. Pub L No. 87-781 §101-308
  • 4
    • 0009718481 scopus 로고    scopus 로고
    • Applications for FDA approval to market a new drug. Adequate and well-controlled studies. 21 CFR 314.126 (2000)
  • 5
    • 0009737840 scopus 로고    scopus 로고
    • Public Health Service Act. 42 USC §262 (1999)
  • 6
    • 0009694410 scopus 로고    scopus 로고
    • Investigational new drug application. Definitions and interpretations. 21 CFR 312.3 (2000)
  • 7
    • 0009664370 scopus 로고    scopus 로고
    • Investigational new drug application. General provisions. 21 CFR 312.2 (2000)
  • 8
    • 0009711029 scopus 로고    scopus 로고
    • Specific requirements on content and format of labeling for human prescription drugs; revision of the "pediatric use" subsection in the labeling. 59 Federal Register 64240 (1994)
  • 9
    • 0009730537 scopus 로고    scopus 로고
    • Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients. 63 Federal Register 66632 (1998)
  • 10
    • 0009660227 scopus 로고    scopus 로고
    • Food and Drug Administration Modernization Act. Pub L No. 105-115 (1997)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.