
Summary of the Mid-Cycle Communication/Teleconference, January 11, 2015 – 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: 11-Jan-2015 6:02 PM       Initiated by FDA? Yes 

Telephone Number: 

Communication Categorie(s): 
 Other, Mid-Cycle communication with sponsor

Author: RAMACHANDRA NAIK 

Telecon Summary: Summary of the Mid-Cycle communication/teleconference with Novartis was sent by e-mail

FDA Participants: RAMACHANDRA NAIK, ED WOLFGANG AND KIRK PRUTZMAN

Non-FDA Participants: PATRICIA STOEHR, SUE FEKETE 

Trans-BLA Group: No 

Related STNs: None 

Related PMCs: None 

Telecon Body:
 E-mail and attached document attached.

From: Naik, Ramachandra
 To: "Stoehr, Patricia"
 Cc: Wolfgang, Edward; Prutzman, Kirk C; "Fekete, Sue"
 Subject: STN 125546 Mid-Cycle communication document
 Date: Sunday, January 11, 2015 6:01:00 PM
 Attachments: STN 125546 Mid-Cycle Communication.pdf

Dear Dr. Stoehr,

Please see attached the Mid-cycle communication teleconference summary for your records. Please confirm the receipt of this document. If you have any questions about this communication, please contact Kirk Prutzman, Ramachandra Naik 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
