Vaccine Guidance Documents

• Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases (PDF - 57KB)
  12/2011 (This guidance supercedes the guidance document of the same title dated September 2008)
• Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines (PDF - 75KB)
  10/2011 (This guidance finalizes the draft guidance of the same title dated September 2009.)
• Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications (PDF - 406KB)
  2/2010
• Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
  11/2007 (This guidance finalizes the draft guidance of the same title dated February 2005.)
• Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials 9/27/2007
• Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines 5/31/2007
• Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines 5/31/2007
• Guidance for Industry: Development of Preventive HIV Vaccines for Use in Pediatric Populations 5/4/2006
• Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications
  2/2006 (This guidance document finalizes the draft guidance entitled "Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications" dated August 2000.)
• Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information 10/1/2004
• Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines 3/12/2001
• Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol 11/20/2000
• Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product 1/5/1999
• Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1) (PDF - 63KB) 9/8/1998
• Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies (PDF - 49KB) 4/10/1997