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Record of Telephone Conversation, July 26, 2013 - Q-Pan

Submission Type: BLA    Submission ID: 125419/0    Office: OVRR

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

ID Biomedical Corporation of Quebec

Telecon Date/Time: 26-Jul-2013 10:30 AM        Initiated by FDA? Yes

Telephone Number: 610-787-3435

Communication Categorie(s):
1. Information Request


Telecon Summary:
IR regarding a subject with Cronkhite-Canada syndrome

FDA Participants: Carmen Collazo-Custodio, Andrea James, Kirk Prutzman, Jeremy Wally

Non-FDA Participants: Michael Schwartz

Telecon Body:

CBER requested the Case Report Form and source documents for subject number 6229.  CBER also asked GSK to prepare a narrative of the company’s assessment of the diagnosis of Cronkhite-Canada syndrome in this subject.  CBER also clarified that our review is still ongoing and we may have additional request(s) for information in the near future.