Vaccine Guidances and Rules

2008 | 2007 | 2006 | 2005 | 2004 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997

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2008

Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases - 9/8/2008

FEDERAL REGISTER: Revision of the Requirements for Live Vaccine Processing; Direct Final Rule; Confirmation of Effective Date - 3/7/2008

2007

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

2006

Draft Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the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

2005

FEDERAL REGISTER: Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Final Rule and Final Order - 12/15/2005 - (PDF, 96 KB)

FEDERAL REGISTER: Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order - 12/15/2005 - (PDF, 137 KB)

Draft Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications - 2/17/2005

2004

Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information - 10/1/2004 - (PDF, 32 KB)

2002

Federal Register Notice: New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible; Final Rule - 5/31/2002 (aka Animal Rule)

2001

Federal Register Notice; Biological Products; Bacterial Vaccines and Related Biological Products; Revocation of Biologics Licenses - 5/29/2001 -(PDF, 31 KB)

Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines - 3/12/2001 - (PDF, 378 KB)

2000


Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol - 11/20/2000- (PDF, 49 KB)

Draft Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications - 9/8/2000-
(PDF, 53 KB)

FEDERAL REGISTER Biological Products; Bacterial Vaccines and Related Biological Products; Implementation of Efficacy Review; Proposed Order - 5/15/2000 (PDF, 150 KB)

1999

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 - (PDF, 92 KB)

1998

Guidance for Industry: How to Complete the Vaccine Adverse Reporting System Form (VAERS-1) - 9/8/1998- (PDF, 63 KB)

1997

Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies - 4/10/1997 -
(PDF, 49 KB)
 
Updated: September 8, 2008