
Information Request Email, Pregnancy Registry, December 31, 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: 31-Dec-2014 4:01 PM     Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s): 
 1. Information Request

Author: RAMACHANDRA NAIK

Telecon Summary: Follow-up IR regarding Pregnancy Registry

FDA Participants: RAMACHANDRA NAIK, ED WOLFGANG AND KIRK PRUTZMAN

Non-FDA Participants: SUE FEKETE

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:
 E-mail attached/pasted below.


From: Naik, Ramachandra
 To: Fekete, Sue
 Cc: sharon.cang@novartis.com; Stoehr, Patricia; Wolfgang, Edward; Prutzman, Kirk C
 Subject: STN 125546 - Follow up Information Request on Pregnancy Registry
 Date: Wednesday, December 31, 2014 4:01:00 PM

Dear Ms. Fekete:

We have reviewed your submission of December 11, 2014, to the BLA STN 125546 (Meningococcal Group B Vaccine) regarding pregnancy registry. We agree with your proposal to establish a pregnancy registry but we have the following request for additional information.

1. Please provide the projected dates and justification of the proposed dates for the following events pertaining to the pregnancy registry.

Final Protocol Submission:
 Study Completion:
 Final Report Submission:

If you have any questions about this communication, please contact Ramachandra Naik, Kirk Prutzman or Ed Wolfgang at (301) 796-2640.

Regards,
 Ramachandra S Naik, PhD
 Primary Reviewer
 Food and Drug Administration
 CBER/OVRR/DVRPA/RRB3
 HFM-475
 10903 New Hampshire Avenue
 Building 71, Room 3045
 Silver Spring, MD 20993
 Phone: (301) 796-2640
 FAX: (301) 595-1244
