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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, January 13, 2009 - Adenovirus

Submission Type: Original Application Submission ID: 125296/0 Office: OVRR

Product:
Adenovirus Vaccine Live Oral Type 4 and Type 7

Applicant:
Duramed Research Inc.

Telecon Date/Time: 13-JAN-2009 12:00 PM      Initiated by FDA? Yes
Telephone Number: 610-747-2664

Communication Categorie(s):
Information Request

Author: DARLENE HITHE

Telecon Summary:

Requested the PI contact telephone numbers from John Pakulski at Duramed for coordination of the BiMo Inspections.

FDA Participants: Darlene Hithe

Non-FDA Participants: John Pakulski

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

Contacted John Pakulski to request contact telephone numbers for the PI at each site in the Phase 3 clinical study conducted. The telephone numbers for Col. Robert Kuschner and CDR Kevin Russell were request. John Pakulski responded in a subsequent telephone message indicating that both clinical sites used in the study had been returned to regular military use and that the data and PIs were no longer at the clinical sites. John indicated that the data and CRFs were all moved to an off-site storage facility located in Fort Detrick, MD but that all information as well as the PIs were available for inspection.