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

 
 

Submission Type: BLA

Submission ID: 125419/0

Office: OVRR

Product:
 Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Applicant:
 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

Author: CARMEN COLLAZO-CUSTODIO

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.
