
Information Request Email, Endotoxin Testing Specifications, September 15, 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: 15-SEP-2014 04:57 PM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s): 
1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary: 
 Follow up IR regarding endotoxin testing specifications 

Draft Label

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: Monday, September 15, 2014 4:57 PM
 To: Stoehr, Patricia (patricia.stoehr@novartis.com)
 Cc: Wolfgang, Edward; Naik, Ramachandra
 Subject: STN 125546 - Information Request

Dr. Stoehr, 

Please find attached a request for additional information regarding STN 125546 (Meningococcal Group B Vaccine). Please provide your responses to this information request in an Amendment to STN 125546 by September 29, 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 


CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
 OFFICE OF VACCINES RESEARCH AND REVIEW
 DIVISION OF VACCINES AND RELATED PRODUCTS APPLICATIONS

DATE:   SEPTEMBER 15, 2014       PAGES: 2

TO:   NOVARTIS VACCINES AND DIAGNOSTICS, INC

ATTENTION:   PATRICIA STOEHR, PH.D.
 Senior Group Manager Regulatory Affairs
 Novartis Vaccines & Diagnostics

350 Massachusetts Avenue
 Cambridge, MA 02139 
 USA

FAX: (617) 871-8060     TEL: (617) 871-4711

FROM:   KIRK PRUTZMAN, PH.D.
 Regulatory Project Manager
 FAX: (301) 595-1244     TEL: (301) 796-2640

SUBJECT:   STN: BL 125546/0 – Request For Information 

MESSAGE: 

Dear Dr. Stoehr:

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

The following requests are related to your endotoxin testing procedure and data analyses submitted to STN 125546: 
1.CBER requests the details of the data of (b)(4) clinical lots and the analyses performed to justify the bacterial endotoxin specification of ---(b)(4)-------; to include the production dates, BET results and lot numbers of clinical lots, analyst who performed each endotoxin result, estimates of variance components, and calculation of degree of freedom by Satterthwaite’s approximation used in computing the one-sided 99% prediction interval. Please also provide justification for calculating the upper bound of 99% prediction internal on the data in the natural log scale, while the data of (b)(4) batches show no significant deviation from normality. 
2.CBER requests the supporting documentation and calculations for the process capability analysis performed on the (b)(4) batches used to justify the bacterial endotoxin specification of ----(b)(4)-----; to include their production dates, BET results, matrix phase(s) (i.e., DP or DS) and batch/lot numbers. 
3.In addition, CBER requests the details of all production process changes impacting bacterial endotoxin concentrations during the production time frame for both the clinical lots and (b)(4) batches used to justify the bacterial endotoxin specification, as mentioned above, to include the implementation dates and the subsequent lots impacted by the change. 

Please provide your responses to this information request in an Amendment to STN 125546 by September 29, 2014. We recommend that you restate each item and follow it with your explanation or clarification. Use of this format helps organize the relevant information and provides a self-contained document that facilitates future reference. If you have any questions about this communication, please contact Kirk Prutzman, Ramachandra Naik, or Ed Wolfgang at (301) 796-2640.
