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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

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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

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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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