
Information Request Email, October 23, 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: 23-Oct-2014 09:56 AM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s): 
1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary:
 IR regarding the validation of ----(b)(4)---- assay for OMV

FDA Participants: KIRK PRUTZMAN, ED WOLFGANG, RAMACHANDRA NAIK

Non-FDA Participants: PATRICIA STOEHR

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:


From: Prutzman, Kirk C 
 Sent: Thursday, October 23, 2014 9:56 AM
To: Stoehr, Patricia (patricia.stoehr@novartis.com)
 Cc: Wolfgang, Edward; Naik, Ramachandra
 Subject: STN 125546 - Information Request 

Dr. Stoehr,

We have the following request for additional information regarding STN 125546 (Meningococcal Group B Vaccine):

Your responses in amendment 125546/0.14 to our Information Request dated September 12, 2014, have been reviewed and we have following information request regarding the validation of ---(b)(4)------ assay for OMV.
1.Precision results in Table 10 of the validation report (315815-02) show that the result at --(b)(4)-- did not meet acceptance criterion of (b)(4). Therefore, this concentration cannot be part of the validated linear range of the assay. In addition, we indicated in the September 12, 2014, Information Request, that “the sample with concentration of ---(b)(4)--- is out of the range of the standard (calibration) curve” [Table 10 of the validation report (315815-02)] because the calibration range is between ---(b)(4)------------. Based on the results you submitted, your validated linear range is ---(b)(4)--------. Please revise the linear range of your assay and submit for review. Alternately, please provide adequate data in support of the proposed linear range of -----------(b)(4)----. 

Please provide your responses to this information request in an Amendment to STN 125546 by November 7, 2014. 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
