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Preclinical Research

ADDRESSING THE INFORMATIONAL REQUIREMENTS OF REGULATORY AGENCIES IN INTERNATIONAL VACCINE DEVELOPMENT STUART Z. SHAPIRO MD,PhD Vaccine &amp; Prevention Research Program DAIDS/NIAID/NIH sshapiro@niaid.nih.gov.

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CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH. By: Wysteria Hart Sahar Mohammadi. Who is CBER?. Governed by: Section 351 of the Public Health Service Act Sections of the Food Drug and Cosmetics Act. What is CBER?. Regulate biologic products Safe for use Effective

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335 views • 14 slides

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