Vaccines Guidances

FDA Vaccine Guidance Documents:

Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications, March 2010
Draft Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines, September 2009
Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases, September 2008
Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications, October 2007
Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September 2007
Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines, May 2007
Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines, May 2007
Guidance for Industry: Development of Preventive HIV Vaccines for Use in Pediatric Populations, May 2006

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