
Information Request Email, September 18, 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: 18-Sep-2014 09:30 AM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s): 
 1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary: IR Regarding (b)(4) testing results for final drug product

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 [mailto:Kirk.Prutzman@fda.hhs.gov] 
 Sent: Thursday, September 18, 2014 9:30 AM
 To: Stoehr, Patricia
 Cc: Wolfgang, Edward; Naik, Ramachandra
 Subject: STN 125546 - Information Request

Drs. Stoehr,

We have the following request for additional information regarding STN 125546 (Recombinant Meningococcal Group B Vaccine):
1. Please provide the (b)(4) potency testing results (potency estimate and confidence intervals) and dates of manufacture for all final drug product lots tested since implementation of the (b)(4) method. Please include all results that were out of specification.

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
