Manual of Standard Operating Procedures and Policies

Regulatory - Compliance

Review of Export Requests for Investigational Biologics
Under 21 CFR 312.110(b)(2)

 

SOPP 8503.1

Version #1

Removal for Revision Date: Oct. 30, 2003
  1. Purpose
    2.

    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.

  2. Removal for Revision Date
    3.

October 30, 2003

 
Updated: October 30, 2003