
Information Request Email, Clinical Comments, October 7, 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: 07-Oct-2014 04:34 PM     Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s): 
 1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary: 
 Follow up IR regarding Clinical comments sent on September 23, 2014.

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: Tuesday, October 07, 2014 4:34 PM 
 To: Stoehr, Patricia (patricia.stoehr@novartis.com) 
 Cc: Wolfgang, Edward; Naik, Ramachandra 
 Subject: RE: STN 125546 - Information Request

Dr. Stoehr,

When you submit your responses to our September 23, 2014, information request below, please include the following:

1) Please indicate which dataset(s) were used by the macros for generating your responses
 2) Please provide the datasets and code indicated in Item 1 if they were not already provided in the BLA
 3) Please provide the macros used and any specific instructions necessary to reproduce your results

Please let me know if you have any questions.

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

From: Prutzman, Kirk C 
 Sent: Tuesday, September 23, 2014 4:06 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 October 7, 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
