VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
May 16-17, 2001
Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, Maryland
QUESTIONS FOR THE COMMITTEE
Wednesday, May 16
Session 2 – Open Session
1. Please discuss OVRR/CBER’s approach in considering potential risks for the use of 293, PER.C6 and other similar "designer cell substrates" for the production of viral vaccines, including:
2. Please discuss any other safety concerns that should be addressed prior to initiating larger-scale human studies.