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Vaccines, Blood & Biologics

10/10/2008 Record of Telecon

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application Submission ID: 125280/0 Office: OVRR

Product:
Japanese Encephalitis Virus Vaccine Inactivated

Applicant:
Intercell AG

Telecon Date/Time: 10-OCT-2008                          Initiated by FDA? Yes
Telephone Number:

Communication Categorie(s): Advice

Author: DARYLL MILLER

Telecon Summary: Discussion of responses to CR letter. Responses have been accepted by product reviewers including proposed -(b)(4)- assay and validation. Sponsor agreed to provide specifications for protamine sulphate.

FDA Participants:

Daryll Miller
Richard Daemer
Lew Markoff
Li Yu
Barry Falgout
Destry Sillivan

Non-FDA Participants:

Thomas LINGELBACH, COO, Intercell AG
David VENABLES; Site Director, Intercell Biomedical
Christoph KLADE; Technology Development / Clinical Immunology
Murray MCKAY, Quality Operations
Fraser LESLIE; Quality and Regulatory Compliance
Paul WILSON, Intercell USA

Trans-BLA Group: No

Related STNs: None

Related PMCs: None


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