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                Biologics Guidances

Biologics Guidances

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                        General Biologics Guidances Home
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          Vaccine and Related Biological Product GuidancesBiologics Guidances Vaccine and Related Biological Product Guidances
  
  	
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Persons with disabilities having problems accessing any of these files may call CBER's Consumer Affairs Branch 240-402-8010 for assistance.

Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry
	10/2023
	Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry
	3/2022 (Updated March 13, 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	10/2011 (This guidance finalizes the draft guidance of the same title dated September 2009.)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	(This guidance finalizes the draft guidance of the same title dated February 2005.) 11/2007.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	(This guidance document finalizes the draft guidance entitled "Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications" dated August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
	4/1997Fecal 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

                                                                                  Content current as of:
      10/19/2023
              
              
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                        Allergenics Guidances
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          Cellular & Gene Therapy Guidances
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          Vaccine and Related Biological Product Guidances
          Xenotransplantation Guidances


                        General Biologics Guidances
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