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The US Food and Drug Administration Provides a Pathway for Licensing Vaccines for Global Diseases


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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

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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

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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

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12. [No authors listed]

1994 Recommendations of the Advisory Committee on Immunization Practices (ACIP): Typhoid immunization. MMWR 43 1 7

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1993 Recommendations of the Advisory Committee on Immunization Practices (ACIP): Inactivated Japanese encephalitis virus vaccine. MMWR 42 1 15

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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 lekárstvo

Článok vyšiel v časopise

PLOS Medicine


2009 Číslo 7
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