Vaccine Safety: An FDA Perspective
by FDA Center for Biologics Evaluation and Research
This paper by the FDA CBER describes the major components of FDA’s evaluation of a biologics license application for a preventive vaccine, discuss the sources of data that FDA uses to monitor vaccine safety after licensure, and describe interactions between FDA and other governmental agencies in vaccine safety and other vaccine-related activities.
| Published: | 2008 |
| Format: | |
| Length: | 31 pages |
| Type: | White paper |
| Language: | English |
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