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U.S. Department of Health and Human Services

About FDA

Enhance information sharing with other National Regulatory Authorities to discuss approaches to safety and effectiveness of vaccines

Description: In order to reduce duplication and increase regulatory harmony, FDA will share information with foreign regulatory concerning the safety and effectiveness of vaccines. This activity will allow better review of vaccine performance data and speed development of products required to combat global infectious diseases. This measure demonstrates CBER’s commitment to working with the global community to develop vaccines for global public health.

FY 2013 Updates

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

Participated and provided expert advice to the WHO Expert Committee on Biological Standardization (ECBS) and the WHO Advisory Committee on Dengue and other Flavivirus Vaccines, Session on Dengue Vaccines in Clinical Development; Participated and provided expert advice in WHO-organized meetings and teleconferences related to development of Guidelines for Nonclinical Evaluation of Adjuvanted Vaccines, Influenza Vaccine Effectiveness, and Scientific and Regulatory Considerations on the Stability Evaluation of Vaccines under a Controlled Temperature Chain.

Quarter 1

Completed Quarter 1

Participated and provided expert advice in the WHO 3rd Implementation Workshop on Stability Evaluation of Vaccines (Jan. 31 -Feb. 1, 2013). Participated and provided expert advice in the Expert Consultation on Ethical Aspects of Placebo Controlled Vaccine Trials (dates January 17-18, 2013). Participated and provided expert advice in the WHO Consultation on the Composition of Influenza Vaccines for the Northern Hemisphere 2013-2014 (February 14-17, 2013). Participated and provided expert advice in the Third Global Forum on tuberculosis (March 25-27, 2013).

Quarter 2

Completed Quarter 2

Reviewed and provided expert advice on the draft document entitled, “WHO Guidelines on the quality, safety and efficacy of Vi polysaccharide conjugate typhoid” (April 16, 2013). Participated and provided expert advice in the WHO Workshop on the guidelines for Salmonella Typhi Vi Conjugate vaccine concerning manufacturing and preclinical investigations (April 23 – 24, 2013). Participated and provided expert advice in the WHO Implementation Workshop on the Characterization of cell banks for the production of biologicals (May 27-29, 2013). Participated and provided expert advice in the WHO Informal Consultation on the Regulatory Risk Assessment in the Case of Adventitious Agent Finding in a Marketed Vaccine (May 30-31, 2013). Participated and provided expert advice in the WHO Informal Consultation on Stability Evaluation of Vaccines under a Controlled Temperature Chain (June 4-6, 2013).

Quarter 3

Completed Quarter 3

Briefed the National Immunization Program Director for the Republic of China on the FDA approval process during a meeting with the National Vaccine Program Office (September 11, 2013). Activity enhanced information sharing between NRAs; Held dialogue and shared documents (including non-public information) on several product safety issues with multiple foreign regulatory authorities subject to donfidentiality arrangements with the FDA. Activity enhanced information sharing between NRAs; Provided public information to the Drug Regulatory Agency of Peru regarding the maximum allowable concentration of thimerosal in vaccines (August 29, 2013). Activity enhanced information sharing between NRAs.

Quarter 4

Completed Quarter 4

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.