Manual of Standard Operating Procedures and Policies
Regulatory - Compliance |
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Review of Export Requests for Investigational Biologics
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SOPP 8503.1 |
Version #1 |
Removal for Revision Date: Oct. 30, 2003 |
- Purpose
- Removal for Revision Date
The SOPP established procedures to be used by the Center for Biologics Evaluation and Research (CBER) staff for the administrative processing and technical review of requests to export investigational biological products for purposes of conducting clinical studies in other countries. The SOPP is under revision.
October 30, 2003