메뉴 건너뛰기




Volumn 127, Issue SUPPL. 1, 2011, Pages

Food and Drug Administration regulation and evaluation of vaccines

Author keywords

Biologics licensing; Regulation; Vaccine

Indexed keywords

VACCINE;

EID: 79955488319     PISSN: 00314005     EISSN: 10984275     Source Type: Journal    
DOI: 10.1542/peds.2010-1722E     Document Type: Review
Times cited : (42)

References (39)
  • 1
    • 0033515267 scopus 로고    scopus 로고
    • Impact of vaccines universally recommended for children: United States, 1990-1998
    • Centers for Disease Control and Prevention
    • Centers for Disease Control and Prevention. Impact of vaccines universally recommended for children: United States, 1990-1998. MMWR Morb Mortal Wkly Rep. 1999;48(12):243-248
    • (1999) MMWR Morb Mortal Wkly Rep , vol.48 , Issue.12 , pp. 243-248
  • 2
    • 79955499279 scopus 로고    scopus 로고
    • Food Drug and Cosmetic Act, 21 USC §321 (1938)
    • Food Drug and Cosmetic Act, 21 USC §321 (1938)
  • 3
    • 79955488224 scopus 로고    scopus 로고
    • Public Health Service Act, ch 373, title III, §351, 58, Stat. 702, 42 USC §262 (1944)
    • Public Health Service Act, ch 373, title III, §351, 58, Stat. 702, 42 USC §262 (1944)
  • 4
    • 79955501679 scopus 로고    scopus 로고
    • Biologics Control Act of 1902, Pub L No. 57-244, ch 1378, 32 Stat 728
    • Biologics Control Act of 1902, Pub L No. 57-244, ch 1378, 32 Stat 728
  • 6
    • 79955486748 scopus 로고    scopus 로고
    • Code of Federal Regulations, 21 CFR parts 600-680 (2010)
    • Code of Federal Regulations, 21 CFR parts 600-680 (2010)
  • 7
    • 79955519649 scopus 로고    scopus 로고
    • Code of Federal Regulations, 21 CFR parts 210 and 211 (2010)
    • Code of Federal Regulations, 21 CFR parts 210 and 211 (2010)
  • 8
    • 79955489431 scopus 로고    scopus 로고
    • Prescription Drug User Fee Act, Pub L No. 102-571 (1992)
    • Prescription Drug User Fee Act, Pub L No. 102-571 (1992)
  • 9
    • 79955502771 scopus 로고    scopus 로고
    • Food and Drug Administration Modernization Act of 1997, Pub L No. 105115 (1997)
    • Food and Drug Administration Modernization Act of 1997, Pub L No. 105-115 (1997)
  • 10
    • 79955497292 scopus 로고    scopus 로고
    • Best Pharmaceuticals for Children Act, Pub L No. 107-109 (2002)
    • Best Pharmaceuticals for Children Act, Pub L No. 107-109 (2002)
  • 11
    • 79955495831 scopus 로고    scopus 로고
    • Food and Drug Administration Amendments Act of 2007, Pub L No. 110-85 (2007)
    • Food and Drug Administration Amendments Act of 2007, Pub L No. 110-85 (2007)
  • 12
    • 79955497679 scopus 로고    scopus 로고
    • Pediatric Research Equity Act, Pub L No. 108-155 (2003)
    • Pediatric Research Equity Act, Pub L No. 108-155 (2003)
  • 13
    • 79955504262 scopus 로고    scopus 로고
    • Code of Federal Regulations, 21 CFR part 58 (2010)
    • Code of Federal Regulations, 21 CFR part 58 (2010)
  • 15
    • 84893949775 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research US Department of Health and Human Services, Available at Accessed January, 2010
    • Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. Guidance for industry: formal meetings between the FDA and sponsors or applicants. US Department of Health and Human Services, Food and Drug Administration. Available at: www.fda.gov/downloads/drugs/ GuidanceComplianceRegulatoryInformation/guidances/ucm153222.pdf. Accessed January, 2010
    • Guidance for Industry: Formal Meetings between the FDA and Sponsors or Applicants
  • 16
    • 79955520750 scopus 로고    scopus 로고
    • Code of Federal Regulations, 21 CFR 312 (2010)
    • Code of Federal Regulations, 21 CFR 312 (2010)
  • 17
    • 84964594016 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
    • Available at Accessed January, 2010
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonized tripartite guideline: guideline for good clinical practice E6(R1). Available at: www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Efficacy/ Eb-R1-Guideline.pdf. Accessed January, 2010
    • ICH Harmonized Tripartite Guideline: Guideline for Good Clinical Practice E6(R1)
  • 18
    • 79955518414 scopus 로고    scopus 로고
    • Code of Federal Regulations, 21 CFR part 312.42 (2010)
    • Code of Federal Regulations, 21 CFR part 312.42 (2010)
  • 19
    • 79955487861 scopus 로고    scopus 로고
    • Code of Federal Regulations, 21 CFR part 312.21 (2010)
    • Code of Federal Regulations, 21 CFR part 312.21 (2010)
  • 20
    • 79955498913 scopus 로고    scopus 로고
    • Code of Federal Regulations, 21 CFR parts 600-680 (2010)
    • Code of Federal Regulations, 21 CFR parts 600-680 (2010)
  • 21
    • 79955507038 scopus 로고    scopus 로고
    • Code of Federal Regulations, 21 CFR part 600 (2010)
    • Code of Federal Regulations, 21 CFR part 600 (2010)
  • 23
    • 79955516748 scopus 로고    scopus 로고
    • Code of Federal Regulations, 21 CFR 201 and 610.10-610.62 (2009)
    • Code of Federal Regulations, 21 CFR 201 and 610.10-610.62 (2009)
  • 24
    • 79955485662 scopus 로고    scopus 로고
    • Code of Federal Regulations, 21 CFR Part 601.41 (2010)
    • Code of Federal Regulations, 21 CFR Part 601.41 (2010)
  • 25
    • 79955514795 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research US Department of Health and Human Services, Available at Accessed January
    • Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. Guidance for Industry: Fast Track drug development programs-designation, development, and application review. US Department of Health and Human Services, Food and Drug Administration. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM079736.pdf. Accessed January, 2010
    • (2010) Guidance for Industry: Fast Track Drug Development Programs-designation, Development, and Application Review
  • 26
    • 79955514061 scopus 로고    scopus 로고
    • Code of Federal Regulations, 21 CFR part 601.90 (2009)
    • Code of Federal Regulations, 21 CFR part 601.90 (2009)
  • 27
    • 79955507615 scopus 로고    scopus 로고
    • Code of Federal Regulations, 21 CFR 610 (2009)
    • Code of Federal Regulations, 21 CFR 610 (2009)
  • 28
    • 0003795820 scopus 로고    scopus 로고
    • Centers for Disease Control and Prevention Atkinson W, Wolfe S, Hamborsky J, McIntyre L, eds. 11th ed. Washington, DC: Public Health Foundation
    • Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases. Atkinson W, Wolfe S, Hamborsky J, McIntyre L, eds. 11th ed. Washington, DC: Public Health Foundation; 2009
    • (2009) Epidemiology and Prevention of Vaccine-Preventable Diseases
  • 29
    • 79955515185 scopus 로고    scopus 로고
    • National Childhood Vaccine Injury Act, Pub L No. 99-660 (1986)
    • National Childhood Vaccine Injury Act, Pub L No. 99-660 (1986)
  • 30
    • 79955485848 scopus 로고    scopus 로고
    • Center for Biologics Evaluation and Research US Department of Health and Human Services Available at Accessed January, 2010
    • Center for Biologics Evaluation and Research. Guidance for industry: development of preventive HIV vaccines for use in pediatric populations. US Department of Health and Human Services, Food and Drug Administration. Available at: www.fda.gov/downloads/BiologicsBloodVaccines/ GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm092165.pdf. Accessed January, 2010
    • Guidance for Industry: Development of Preventive HIV Vaccines for Use in Pediatric Populations
  • 31
    • 52449105777 scopus 로고    scopus 로고
    • Center for Biologics Evaluation and Research US Department of Health and Human Services, Available at Accessed January, 2010
    • Center for Biologics Evaluation and Research. Guidance for industry: considerations for plasmid DNA vaccines for infectious disease indications. US Department of Health and Human Services, Food and Drug Administration. Available at: www.fda.gov/downloads/BiologicsBloodVaccines/ GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm091968.pdf. Accessed January, 2010
    • Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
  • 33
    • 84912548425 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
    • Available at Accessed January, 2010
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH tripartite guideline. Pharmaceutical Quality System Q10. Available at: www.ich.org/fileadmin/Public- Web-Site/ICH-Products/Guidelines/Quality/Q10/Step4/Q10-Guideline.pdf. Accessed January, 2010
    • ICH Tripartite Guideline. Pharmaceutical Quality System Q10
  • 34
    • 79955511602 scopus 로고    scopus 로고
    • Center for Biologics Evaluation and Research US Department of Health and Human Services, Available at: Accessed January, 2010
    • Center for Biologics Evaluation and Research. Draft Guidance for industry: process validation: general principles and practices. US Department of Health and Human Services, Food and Drug Administration. Available at: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM070336.pdf. Accessed January, 2010
    • Draft Guidance for Industry: Process Validation: General Principles and Practices
  • 35
    • 67650525891 scopus 로고    scopus 로고
    • Center for Biologics Evaluation and Research US Department of Health and Human Services, Available at Accessed January, 2010
    • Center for Biologics Evaluation and Research. Guidance for industry: Clinical data needed to support the licensure of pandemic influenza vaccines. US Department of Health and Human Services, Food and Drug Administration. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/ GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm091985.pdf. Accessed January, 2010
    • Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
  • 36
    • 64549114375 scopus 로고    scopus 로고
    • Center for Biologics Evaluation and Research US Department of Health and Human Services, Available at: Accessed January, 2010
    • Center for Biologics Evaluation and Research. Guidance for industry: Clinical data needed to support the licensure of seasonal inactivated influenza vaccines. US Department of Health and Human Services, Food and Drug Administration. Available at: www.fda.gov/downloads/BiologicsBloodVaccines/ GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm091990.pdf. Accessed January, 2010
    • Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines
  • 37
    • 78649271687 scopus 로고    scopus 로고
    • Center for Biologics Evaluation and Research US Department of Health and Human Services, Available at Accessed January, 2010
    • Center for Biologics Evaluation and Research. Guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. US Department of Health and Human Services, Food and Drug Administration. Available at: www.fda.gov/downloads/ BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/ Vaccines/ucm091977.pdf. Accessed January, 2010
    • Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
  • 38
    • 79955501322 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
    • Available at Accessed January, 2010
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Tripartite Guideline. Detection of toxicity to reproduction for medicinal products and toxicity to male fertility S5(R2). Available at: www.ich.org/fileadmin/Public-Web-Site/ICH- Products/Guidelines/Safety/S5-R2/Step4/S5-R2-Guideline.pdf. Accessed January, 2010
    • ICH Tripartite Guideline. Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to Male Fertility S5(R2)
  • 39
    • 79955507230 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
    • Available at Accessed January, 2010
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Tripartite Guideline. Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. Available at: www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/ Safety/S6-R1/Step4/S6-Guideline.pdf. Accessed January, 2010
    • ICH Tripartite Guideline. Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.