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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Conversation, January 27, 2009 - Adenovirus Vaccine

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

Communication Categorie(s):
Information Request


Telecon Summary:
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

Telecon Body:
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.