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The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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| Guidance for Industry
Considerations for Plasmid DNA Vaccines for Infectious Disease Indications |
| Internet: | http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm091968.pdf |
| Origin/Publisher: | Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ |
| Content: | This guidance describes our current recommendations concerning preclinical development and testing of DNA vaccines to prevent infectious diseases. This guidance supercedes the 1996 Points to Consider document. In addition, this guidance finalizes the draft guidance of the same title dated February 2005. |
| Document Type: | Guidance for Industry |
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