
Information Request Email, Risk Management Plan, August 26, 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: 26-Aug-2014 04:35 PM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s): 
1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary: 
IR regarding the Risk Management Plan

FDA Participants: KIRK PRUTZMAN, RAMACHANDRA NAIK, ED WOLFGANG

Non-FDA Participants: PATRICIA STOEHR

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body: 


From: Prutzman, Kirk C 
 Sent: Tuesday, August 26, 2014 4:35 PM
 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 (Recombinant Meningococcal Group B Vaccine):
1.The following comment pertains to the Risk Management Plan (version 5) that is located in module 1.16.
 On pages 78-79, section 10.4.3, Table 10-19, you listed the proposed post-marketing studies and stated that the protocols were either already submitted to or endorsed by the EMA, or discussed with the Canadian IMPACT or the Australian PAEDS network. Please submit an update on the status of each study listed in the table, and submit protocols for all post-marketing studies that you are planning to conduct outside the US. 
2.The following comment pertains to the Risk Management Plan (version 5) that is located in module 1.16.
 On page 45 of 136, section 6 “Part II Safety Specification Module SV: Post-authorization experience”, you stated “Very limited spontaneous adverse event data were available at the time of the data lock point (13 January 2014). Only five spontaneous adverse events have been reported in the (b)(4) database. All are expected and no case has been reported as serious.” Please submit any updates of reports and details of AEs and SAEs in the 6 months since the data lock point (13 January 2014). 

Please provide your responses to this information request in an Amendment to STN 125546. 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.

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 
