
Information Request Email, August 20, 2014 - BEXSERO


 

 
RECORD OF TELEPHONE CONVERSATION

Submission Type: BLA     Submission ID: 125546/0     Office: OVRR 

Product:
 Meningococcal Group B Vaccine 

Applicant:
 Novartis Vaccines and Diagnostics, Inc. 

Telecon Date/Time: 20-Aug-2014 03:34 PM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s): 
 1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary: 
 IR regarding NVD's response to Item 1 submitted in Amendment 7 - STN 125546/0.7

FDA Participants: KIRK PRUTZMAN, ED WOLFGANG, RAMACHANDRA NAIK

Non-FDA Participants: PATRICIA STOEHR, GIOVANNI GARZELLA

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body: 


From: Prutzman, Kirk C
 Sent: Wednesday, August 20, 2014 3:34 PM
 To: Garzella, Giovanni (giovanni.garzella@novartis.com); Stoehr, Patricia (patricia.stoehr@novartis.com)
 Cc: Wolfgang, Edward; Naik, Ramachandra
 Subject: STN 125546 Information Request - Amendment 7

Drs. Stoehr and Garzella,

We have the following request for additional information regarding your response to Item 1 in the Information Request dated July 15, 2014, which was submitted in your Amendment dated August 19, 2014 (STN 125546/0.7):


1.The annotation provided with the data submitted in response to CBER Item 1 is insufficient. Please provide annotation for the data submitted in attachment 1.2 that clearly labels the test run and the test date such that the individual test runs can be identified. Please ensure that the appropriate reference vaccine data can be associated with the test vaccine data for each run and the each run has a unique identifier. 
Please provide your responses to this information request in an Amendment to STN 125546. If you have any questions about this communication, please contact Kirk Prutzman, Ramachandra Naik, or Ed Wolfgang at (301) 796-2640. 

Regards,

Kirk Prutzman, PhD Primary Reviewer/Regulatory Project Manager 
 CBER/OVRR/DVRPA/CMC3 
 Food and Drug Administration
 10903 New Hampshire Avenue
 Building 71 and Room 3041
 Silver Spring, MD 20993-0002
 Phone: (301) 796-2640
 Fax: (301) 595-1244 
