The US Food and Drug Administration Provides a Pathway for Licensing Vaccines for Global Diseases
article has not abstract
Vyšlo v časopise:
The US Food and Drug Administration Provides a Pathway for Licensing Vaccines for Global Diseases. PLoS Med 6(7): e32767. doi:10.1371/journal.pmed.1000095
Kategorie:
Policy Forum
prolekare.web.journal.doi_sk:
https://doi.org/10.1371/journal.pmed.1000095
Souhrn
article has not abstract
Zdroje
1. Food and Drug Administration 2008 Guidance for industry: General principles for the development of vaccines to protect against global infectious diseases. Available: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm074762.htm. Accessed 17 June 2009
2. LaForceFM
KondeK
VivianiS
PreziosiMP
2007 The Meningitis Vaccine Project. Vaccine 25 (Suppl 1) A97 A100
3. BejonP
LusinguJ
OlotuA
LeachA
LievensM
2008 Efficacy of RTS,S/AS01E vaccine against malaria in children 5 to 17 months of age. N Engl J Med 359 2521 2532
4. SkeikyYAW
SadoffJC
2006 Advances in tuberculosis vaccine strategies. Nat Rev Microbiol 4 469 476
5. JohnstonMI
FauciAS
2008 An HIV vaccine—Challenges and prospects. N Engl J Med 359 888 890
6. WalkerRI
2005 New vaccines against enteric bacteria for children in less developed countries. Expert Rev Vaccines 4 807 812
7. HotezPJ
MolyneuxDH
FenwickA
KumaresanJ
SachsSE
2007 Control of neglected tropical diseases. N Engl J Med 357 1018 1027
8. BrennanMJ
FruthU
MilstienJ
TiernanR
de Andrade NishiokaS
2007 Development of new tuberculosis vaccines: A global perspective on regulatory issues. PLoS Med 4 e252 doi:10.1371/journal.pmed.0040252
9. European Medicines Agency 2005 Guideline on procedural aspects regarding a CHMP scientific opinion in the context of cooperation with the World Health Organisation (WHO) for the evaluation of medicinal products intended exclusively for markets outside the community. Available: http://www.emea.europa.eu/pdfs/human/regaffair/557904en.pdf. Accessed 17 June 2009
10. World Health Organization 2006 Procedures for assessing the acceptability of vaccines for purchase by United Nations agencies. Available: http://www.path.org/vaccineresources/files/Procedures_acceptability_purchase_by_UN.pdf. Accessed 17 June 2009
11. MilstienJ
DellepianeN
LambertS
BelgharbiL
RollsC
2002 Vaccine quality—Can a single standard be defined? Vaccine 2956 1 4
12. [No authors listed]
1994 Recommendations of the Advisory Committee on Immunization Practices (ACIP): Typhoid immunization. MMWR 43 1 7
13. [No authors listed]
1993 Recommendations of the Advisory Committee on Immunization Practices (ACIP): Inactivated Japanese encephalitis virus vaccine. MMWR 42 1 15
14. OlinP
RasmussenF
GustafssonL
HallanderHO
HeijbelH
1997 Randomized controlled trial of two-component, three-component and five-component acellular pertussis vaccines compared with whole-cell pertussis vaccine. Ad Hoc Group for the Study of Pertussis Vaccines. Lancet 350 1569 1577
15. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research 2008 Guidance for industry: Tropical disease priority review vouchers. Available: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM080599.pdf. Accessed 23 June 2009
Štítky
Interné lekárstvoČlánok vyšiel v časopise
PLOS Medicine
2009 Číslo 7
- Statinová intolerance
- Očkování proti virové hemoragické horečce Ebola experimentální vakcínou rVSVDG-ZEBOV-GP
- Parazitičtí červi v terapii Crohnovy choroby a dalších zánětlivých autoimunitních onemocnění
- Metamizol v liečbe pooperačnej bolesti u detí do 6 rokov veku
- Co dělat při intoleranci statinů?
Najčítanejšie v tomto čísle
- Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement
- The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration
- The US Food and Drug Administration Provides a Pathway for Licensing Vaccines for Global Diseases
- Ethics Without Borders