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Vaccines

Record of Telephone Conversation, November 20, 2012 - 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: 20-Nov-2012 04:13 AM        Initiated by FDA? Yes

Telephone Number: michael.p.schwartz@gsk.com; robert.d.brobst@gsk.com, Jillian.M.horvath@gsk.com

Communication Categorie(s):
1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary:
IR regarding Amendment 16 submitted on November 15, 2012

FDA Participants: KIRK PRUTZMAN, CARMEN COLLAZO, JEREMY WALLY

Non-FDA Participants: MICHAEL SCHWARTZ, ROBERT BROBST, JILLIAN HORVATH

Trans-BLA Group: No

Related STNs: None
Related PMCs: None
Telecon Body:

From:                     Prutzman, Kirk C
Sent:                      Tuesday, November 20, 2012 4:13 PM
To:                         Prutzman, Kirk C; 'Michael Schwartz'; 'Robert Brobst'; 'Jillian Horvath'
Cc:                         Collazo, Carmen; Wally, Jeremy
Subject:                 STN 125419 - Qpan IR regarding Amendment 16
Dear Drs. Schwartz, Brobst, and Horvath,

We have the following additional Information Request (IR) regarding Amendment 16 submitted on November 15, 2012 (125419/16). 

  1. Please clarify whether the age cohort in Tables 3, 10, 17, 24, 31 and 38 in Analysis_E1_08 should be "75 years of age or older" (per the submission) or "65 years of age or older".

 

Please submit your responses in an amendment to the BLA submission.  If you have any questions about this communication, please contact Kirk Prutzman, Carmen M. Collazo, or Jeremy Wally.

Regards, 

Kirk Prutzman, PhD
Food and Drug Administration
Primary Reviewer/Regulatory Project Manager
CBER/OVRR/DVRPA/CMC3
1451 Rockville Pike (WOC2)
Room 2241
HFM-481
Rockville, MD  20857
Phone:  (301) 796-2640