2006D-0383 Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
FDA Comment Number : EC2435
Submitter : Mrs. Sharon Harrigan Date & Time: 12/01/2006 08:12:57
Organization : Mrs. Sharon Harrigan
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
It is unacceptable to use cell lines from aborted fetal tissue when there are other viable acceptable alternatives available. Please do not approve the use of these cell lines when making vaccines.