Vaccine and Related Biological Product Guidances

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• 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  10/2011 (This guidance finalizes the draft guidance of the same title dated September 2009.)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  (This guidance finalizes the draft guidance of the same title dated February 2005.) 11/2007.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  (This guidance document finalizes the draft guidance entitled "Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications" dated August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• Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines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 Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol
  11/2000

• 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

Persons with disabilities having problems accessing any of these files may call CBER's Consumer Affairs Branch 240-402-8010 for assistance.

• Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Guidance for Industry:
  11/2022