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Vaccines, Blood & Biologics

Record of Telephone Conversation, October 18, 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: 18-Oct-2012 10:12 AM Initiated by FDA? Yes
Telephone Number: michael.p.schwartz@gsk.com; robert.d.brobst@gsk.com

Communication Categorie(s):
1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary:
IR Regarding Anti-Microbial Effectiveness Testing
FDA Participants: KIRK PRUTZMAN, CARMEN COLLAZO, JEREMY WALLY
Non-FDA Participants: MICHAEL SCHWARTZ, ROBERT BROBST

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:


From:Prutzman, Kirk C
Sent:Thursday, October 18, 2012 10:12 AM
To:'Michael Schwartz'; Robert Brobst
Cc:Collazo, Carmen; Wally, Jeremy
Subject:STN 125419 - Qpan - Information Request

Dear Drs. Schwartz and Brobst,

We have the following request for additional information regarding Anti-Microbial Effectiveness Testing for STN 125419 (Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted):

  1. For preservative efficacy in 3.2.P.2.5, Pharmaceutical Development, Microbial Attributes, the protocol provided does not provide enough detail regarding the procedure. Please submit a detailed SOP used for anti-microbial effectiveness testing to include the amount of sample removed and tested at each time point, procedure for-------(b)(4)------------ including type of agar, temperature and incubation duration for each ---(b)(4)---.

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, MD20857
Phone:(301) 796-2640

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