
Information Request Email, July 30, 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: 30-Jul-2014 02:26 PM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s): 
1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary: 
IR / Clarfication regarding information submitted in STN 125546/0.3

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: Wednesday, July 30, 2014 2:26 PM
 To: Stoehr, Patricia (patricia.stoehr@novartis.com)
 Cc: Wolfgang, Edward; Naik, Ramachandra
 Subject: STN 125546 Information Request / Clarification 

Dr. Stoehr,

We have the following clarification questions regarding your Amendment dated July 27, 2014 (STN 125546/0.3). 

You state that “The (b)(4) floor [Building (b)(4)] consists of the -----------(b)(4)------------ (serving the (b)(4) building), as well as ----(b)(4)----- used for the production of antigens for the Menveo product (US licensed). “, and then state that “There is also a (b)(4) purification area (purification (b)(4)) on the (b)(4) floor dedicated for -------(b)(4)-------- (currently not licensed and not utilized for commercial production).”
1.Please clarify what US approved Menveo manufacturing steps (i.e. fermentation, purification, conjugation, etc.) are performed on the ---(b)(4)--- floor.
2.What are the -----(b)(4)----- products manufactured in -------(b)(4)-------- area being used for? Please provide your responses to this information request in an Amendment to STN 125546 by COB August 1, 2014. To expedite review, you may also submit the electronic documents directly to Kirk Prutzman (kirk.prutzman@fda.hhs.gov) via email prior to officially submitting them to the BLA. In the cover letter of your Amendment, please indicate any documents that were emailed to CBER prior to submission and state that the documents in the Amendment are the same as the documents that were emailed to CBER. 

We recommend that you restate each item and follow it with your explanation or clarification. Use of this format helps organize the relevant information and provides a self-contained document that facilitates future reference. 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
