| 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. | ||||||||||||||||||||||||