
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 12:56 PM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s): 
1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary: 
IR Regarding DS -(b)(4)- testing

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 12:56 PM
 To: Stoehr, Patricia (patricia.stoehr@novartis.com)
 Cc: Wolfgang, Edward; Naik, Ramachandra
 Subject: STN 125546 Information Request

Dr. Stoehr,

We have following Information Request after reviewing the -(b)(4)- methods (--(b)(4)-- AP 63.470 Ed 5.0; --(b)(4)-- AP 63.471 Ed 6.0 and --(b)(4)-- AP 63.472 Ed 5.0):
1.All three SOPs are stamped “not for Operational Use”. Please provide operational SOPs for these assays.
2.Please confirm there are four data points in the linearity of molecular mass calibration curve. 
3.For SOP AP 63.471, do you use manual integration to calculate areas of the -------------------------------(b)(4)-------------------------------------------------- to decide the impurity percentage of a sample? 
4.For SOP AP 63.472:
a.Please describe the blank solution. 
b.In section 4.6 of SOP, it states that there are (b)(4) dummy injections. But in the sequence example there are (b)(4) dummy injections. Please clarify the actual number of dummy injections. 
c.Do you use manual integration to calculate areas of the -----------(b)(4)--------------------

Please provide your responses to this information request in an Amendment to STN 125546 by COB August 6, 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
