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Vaccines, Blood & Biologics

Record of Telephone Conversation - May 29, 2009 - Prevnar 13

System Info - 101583  SHONE, DEANNA   06-Aug-2009 16:26:59  SHONEDE

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125324/0    Office: OVRR  

Product:

Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Applicant:
Wyeth Pharmaceuticals Inc.          

Telecon Date/Time:  29-MAY-2009       Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):
Information Request

Author:  COLLEEN SWEENEY

Telecon Summary:
RE: E-mail regarding serological validation assays

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH


Memorandum

Date: May 29, 2009
To:

Carmel Devlin, Associate Director
Global Regulatory Affairs,
Wyeth Pharmaceuticals Inc.

From:CDR C. Sweeney, MS, Regulatory Coordinator
CC:

Lev Sirota, Ph.D., Statistical Reviewer
Julienne Vaillancourt, R.Ph.,M.P.H.,Chair
LCDR Mike Smith, Ph.D. Regulatory Coordinator

Subject:Validation data for serological assays

Based on review of the statistical analysis of validation data for serological assays of your BLA (STN 125324),

Dr. Lev Sirota has the following comment in regard to section 5.3.1.4, Reports of Bioanalytical and Analytical Methods for Human Studies, sub-section stf Polio Neut Sabin:

In the Polio Neut Sabin section 2.6.1, (Linearity on Page 16, please submit scatter plots with regression line and residual plots for linear regression analysis presented in Table 2-10.

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

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