|
National Vaccine Program OfficeDHHS ReportsCDCNational Immunization Program Strategic Plan Protecting the Nation's Health in an Era of Globalization: CDC's Global Infectious Disease Strategy FDAFederal Register Notice; Biological Products; Bacterial Vaccines and Related Biological Products; Revocation of Biologics Licenses - 5/29/2001 - (PDF), (Text) Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines - 3/12/2001 - (PDF), (Text) Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol - 11/20/2000 - (PDF), (Text) Draft Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications - 9/8/2000 - (PDF), (Text)
FEDERAL REGISTER
Biological Products;
Bacterial Vaccines and
Related Biological
Products; Implementation
of Efficacy Review;
Proposed Order -
5/15/2000 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 - (PDF), (Text) Guidance for Industry: How to Complete the Vaccine Adverse Reporting System Form (VAERS-1) - 9/8/1998 - (PDF), (Text) Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies - 4/10/1997 - (PDF), (Text)
Points to Consider on
Plasmid DNA Vaccines for
Preventive Infectious
Disease Indications -
12/27/1996 Workshop on Non-Clinical Safety Evaluation of Preventive Vaccines: Recent Advances and Regulatory Considerations - December 2 - 3, 2002 Transcripts - 12/2/02 - (292 pages) (PDF), (Text) Workshop on Evolving Scientific and Regulatory Perspectives on Cell Substrates for Vaccine Development - September 7 - 10, 1999 Handout - A Defined-Risks Approach to the Regulatory Assessment of the Use of Neoplastic Cells as Substrates for Viral Vaccine Manufacture (PDF) Transcripts -
09/07/99 - (87 Pages)
(Text) FDA-NCI Workshop on Tumor Vaccines - December 10 and 11, 1998 Transcript -
12/10/98 -
(PDF)
Simian Virus 40: A
Possible Human
Polyomavirus Workshop
- January 27 & 28,
1997
January 27 -
Transcript Part
1 (170
pages) NIHJordan Report 20th Anniversary: Accelerated Development of Vaccines 2002 Vaccine Research Center Strategic Plan GAO Reports Childhood Vaccines: Ensuring an Adequate Supply Poses Continuing Challenges, September 2002 Calling the Shots: Immunization Finance Policies and Practice, June 16, 2000 Financing Vaccines in the 21st Century: Assuring Access and Availability, August 4, 2003 Scientific and Policy Implications in Developing Smallpox Immunization Options IOM Setting the Course Series Following the publication of Calling the Shots, IOM convened three regional workshops and one national workshop to review the findings and recommendations of the report and to identify areas of consensus as well as unresolved concerns that require future attention by public and private officials in strengthening the national immunization system. The workshops were designed not only to foster awareness about the Calling the Shots report, but also to strengthen interactions among public- and private-sector health officials to build consensus about immunization initiatives, and to identify unresolved public health and health finance issues and concerns at the regional, state, and local levels that require further attention from public and private policymakers. The regional workshops were held in Chicago, Austin, and Los Angeles; summaries of each workshop are available. Setting the Course, A Strategic Vision for Immunization Finance, The Chicago Workshop, January 2001
Setting the Course: A
Strategic Vision for
Immunization. Part 2
Summary of the Austin
Workshop Setting the Course: A Strategic Vision for Immunization Part 3: Summary of the Los Angeles Workshop, February 2003 Setting the Course: A Strategic Vision for Immunization Part 4: Summary of the Washington DC Workshop, November, 2003 Immunization Safety Review Immunization Safety Review: Influenza Vaccines and Neurological Complications, October 6, 2003 Immunization Safety Review: Vaccinations and Sudden Unexpected Death in Infancy March 12, 2003 Immunization Safety Review: SV40 Contamination of Polio Vaccine, October 22, 2002 Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders May 30, 2002 Immunization Safety Review: Multiple Immunizations and Immune Dysfunction, February 20, 2002 Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism, April 23, 2001 Risk Communication Science and Risk Communication: A mini-symposium sponsored by the EHSRT WHO Assessing New Vaccines for National Immunization Programmes (PDF) (274KB) |
Last revised: November 8, 2005