
Information Request Email, August 14, 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: 14-Aug-2014 02:46 PM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s): 
1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary: 
IR/Clarification regarding Item 3 fin the 7/15/2014 IR. 

FDA Participants: KIRK PRUTZMAN, ED WOLFGANG, RAMACHANRA NAIK

Non-FDA Participants: PATRICIA STOEHR, GIOVANNI GARZELLA

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body: 


From: Prutzman, Kirk C 
 Sent: Thursday, August 14, 2014 2:46 PM
 To: 'Garzella, Giovanni'; Stoehr, Patricia
 Cc: Wolfgang, Edward; Naik, Ramachandra
 Subject: RE: STN 125546 Information Request July 15 - Request #3 Fully annotated files

Dear Drs. Stoehr and Garzella,

In response to your question for Item 3 in the Information Request from CBER dated July 15, 2014, regarding the term “fully annotated”, we have the following clarification:

CBER expects your response to Item 3 in the July 15, 2014, Information Request to include the “raw” (b)(4) O.D. values from assays run in (b)(4) well plates. We expect the data format will likely be presented in a -(b)(4)- array. We will need to know the locations of the references, controls, and samples along with the dilutions of each sample, reference and control run. Please include these annotations as necessary and any other annotations that may be relevant in your response to Item 3 in an Amendment to your BLA (STN 125546).

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

From: Garzella, Giovanni [mailto:giovanni.garzella@novartis.com]
 Sent: Thursday, August 14, 2014 2:39 PM
 To: Prutzman, Kirk C; Wolfgang, Edward; Naik, Ramachandra
 Cc: Stoehr, Patricia
 Subject: STN 125546 Information Request July 15 - Request #3 Fully annotated files

Dear Dr. Prutzman,

Following our quick TC re to the clarification of fully annotated files as per IR #3 (repeated below) in CBER IR emailed to Dr Stoehr last July 15 I would really appreciate if you could email me today details of what you explained to me so I can be sure that my team fully understand your reviewer request and can work to properly address that. Not sure in fact whether you spoke about OD valued of -----------(b)(4)---------- images for control location etc…or I have misunderstood.

“Please provide the (b)(4) titer data for each animal, used to generate the summary in Table 3.2.P.5.3.3-1 estimating the number of OOS, OOL and invalid assays based on the calculation methods tested. Please verify the system suitability criteria used to invalidate assays for each calculation method. Please provide the data in a readable file format and fully annotated.” 

Best regards,
 Giovanni Garzella
