Submission Type: Original Application Submission ID: 125296/0 Office: OVRR
Adenovirus Vaccine Live Oral Type 4 and Type 7
Duramed Research Inc.
Telecon Date/Time: 27-JAN-2009 09:00 AM Initiated by FDA? Yes
Telephone Number: 610-747-2664
Author: DARYLL MILLER
Requested the location of the General Safety Test within the orginal BLA. Sponsor submitted GST as amendment 003 on 2/3/09.
FDA Participants: Daryll Miller
Non-FDA Participants: John Pakulski
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
The Sponsor was contacted because the review team was having difficulty finding the General Safety Test in the original submission. The Sponsor emailed a copy of the GST protocol but it was incomplete because it did not contain adequate sample preparation procedures. The Sponsor was notified on January 28, 2009 that the sample preparation procedures were missing. The Sponsor subsequently submitted the GST with sample preparation procedures as an official amendment 125296/0/003 to the BLA on February 3, 2009.