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 : EC5258
Submitter : Dr. Maria Harper Date & Time: 12/29/2006 08:12:50
Organization : University of Pittsburgh
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Please only use those human cell lines for medical research or pharmaceutical or other products that have been derived from adults who are capable of giving and have given their informed consent.