The objective of this contract is the production of FDA-required documentation in support of an Investigational New Drug (IND) application. This includes the development for specific vaccines of the Master File, Investigator's Brochure and compilation of an IND application including a vaccine trial protocol appropriate for submission to CBER, FDA for an IND. The contractor must also work together with other contractors performing safety and immunogenicity testing of the vaccine product or manufacturing the specific vaccine product.

Project Start
1999-06-30
Project End
2006-06-29
Budget Start
2000-05-15
Budget End
2001-07-15
Support Year
Fiscal Year
2000
Total Cost
$110,985
Indirect Cost
Name
Sri International
Department
Type
DUNS #
City
Menlo Park
State
CA
Country
United States
Zip Code
94025