
Information Request Email, Endotoxin Testing Specifications, August 22, 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: 22-Aug-2014 02:12 PM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s): 
1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary: 
IR regarding endotoxin testing specifications

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: Friday, August 22, 2014 2:12 PM 
 To: Stoehr, Patricia (patricia.stoehr@novartis.com); Garzella, Giovanni (giovanni.garzella@novartis.com)
 Cc: Wolfgang, Edward; Naik, Ramachandra
 Subject: STN 125546 Information Request

Drs. Stoehr and Garzella,

We have the following request for additional information regarding STN 125546 (Recombinant Meningococcal Group B Vaccine):
1. CBER finds your bacterial endotoxin specification of -----(b)(4)----- does not reflect your production process capability, as the lots submitted in support of this application have a bacterial endotoxin concentration that is over 2 fold lower than the specification. Please lower this specification so it is more in-line with your process capability. 

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 
