
Update of M3 CTD Dossier Sections Email, November 5, 2014 - BEXSERO

 

 
(System Info - 297317 WOLFGANG EDWARD 01/28/2015 10:58:57 WOLFGANG)

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: 05-Nov-2014 03:12 PM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s): 1. Advice

Author: EDWARD WOLFGANG

Telecon Summary: 
an update of M3 CTD dossier sections 

FDA Participants: None

Non-FDA Participants: None

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body: 


From: Prutzman, Kirk C 
 Sent: Wednesday, November 05, 2014 3:12 PM
 To: Stoehr, Patricia; Wolfgang, Edward; Naik, Ramachandra
 Subject: RE: Bexsero BLA 125546-Regulatory question on M3 section update

Dr. Stoehr,

CBER agrees with your proposal below.

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: Stoehr, Patricia [mailto:patricia.stoehr@novartis.com] 
 Sent: Friday, October 31, 2014 6:39 PM
 To: Prutzman, Kirk C; Wolfgang, Edward; Naik, Ramachandra
 Subject: Bexsero BLA 125546-Regulatory question on M3 section update

Dear Dr. Prutzman,

Several of the CMC Information Requests we’ve received for Bexsero will require an update of M3 CTD dossier sections. As Novartis has informed you in sequence 0013 already we will provide these updated sections as soon as they become available.

We are planning to submit the revised facility sections 3.2.A.1 during the first week in November followed by a second submission on all other M3 sections which are impacted by our responses to CBERs CMC IRs mid of November. We will make only updates which are caused by the IR.

Does CBER agree?

Best regards, Patricia

*********************************
 Patricia Stoehr
 Director Regulatory Affairs 
 Novartis Vaccines & Diagnostics
 350 Massachusetts Avenue
 Cambridge, MA 02139 
 USA
 Phone: +1 617 871-8060
 Fax: +1 617 871-4711
 Email : patricia.stoehr@novartis.com
 ***************************************

[Enter details of telecon here]
