  


Information Request Email, Pregnancy Registry, December 2, 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: 02-Dec-2014 3:55 PM     Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s): 
 1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary: 
 IR regarding a Pregnancy Registry

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, December 02, 2014 3:55 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 (Meningococcal Group B Vaccine).

Please provide as soon as possible your plans to establish a pregnancy registry or a post-marketing observational study in pregnant women exposed to Bexsero in the U.S. to evaluate pregnancy and birth outcomes following exposure to Bexsero during pregnancy. Please submit either:

a) A protocol for a U.S. Pregnancy Registry that addresses the elements found in the FDA’s Guidance for Industry on Establishing Pregnancy Registries. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071639.pdf?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=Varicella%20pregnancy%20registry&utm_content=2 

Please notify CBER of significant deviations from this guidance and specify the deviations in the protocol.

Or

b) A protocol for a post-marketing observational pregnancy study using electronic healthcare data.

Please provide the dates that the concept protocol and the final protocol will be submitted to CBER.

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
