Vaccine Guidance Documents

• Draft Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines 
  09/2009
• Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases 
  9/8/2008
• Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications 
  10/29/2007
• 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
• Draft Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases 
  9/28/2006
• 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 
  2/13/2006
• Draft Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications 
  2/17/2005
• 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• Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines 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
• Draft Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications 
  9/8/2000
• 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