
Information Request Email, November 17, 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: 17-Nov-2014 4:22 PM     Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s): 
 1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary:
 IR regarding timeline for reassessment and submission of data indicated in Amendment 23

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, November 17, 2014 4:22 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 your responses to CBER’s Information Request dated October 8, 2014, submitted on October 31, 2014, in Amendment 23 to STN 125546 (Meningococcal Group B Vaccine):

In your “Responses to CBER’s Request for Information”, you stated “As such the company intends to re-assess the process capability and specification once a sufficiently dataset, including the 2014 production campaigns, becomes available. Following reassessment, the -----(b)(4)----- specification for rp287-953 drug substance will be updated accordingly and implemented in the next rp287-953 drug substance manufacturing campaign.” (page 74 of 75). Please provide the timeline for reassessment and submission of your data.

Please provide your responses to this information request in an Amendment to STN 125546 by November 24, 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
