Vaccine and Related Biological Product Guidances
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Vaccine and Related Biological Product Guidances by Year
- Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry
10/2023 - Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review; Guidance for Industry; Technical Specifications Document
12/2019 - Providing Submissions in Electronic Format-Postmarketing Safety Reports for Vaccines - Guidance for Industry
8/2015
- Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases
12/2011 (This guidance supercedes the guidance document of the same title dated September 2008) - Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines
10/2011 (This guidance finalizes the draft guidance of the same title dated September 2009.)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
2/2010 - Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
(This guidance finalizes the draft guidance of the same title dated February 2005.) 11/2007. - Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
9/2007 - Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
5/2007 - Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines
5/2007 - Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications
(This guidance document finalizes the draft guidance entitled "Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications" dated August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.) 2/2006 - Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information
10/2004 - Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines
3/2001
- Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product
1/1999 - Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1)
9/1998 - Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies
4/1997
Fecal Microbiota for Transplantation
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