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Vaccines, Blood & Biologics

Record of Telephone Conversation - December 3, 2009-2 - Prevnar 13

System Info - 120218 SMITH, MICHAEL J 17-Feb-2010 11:54:15 SMITHM


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

Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Wyeth Pharmaceuticals Inc.

Telecon Date/Time: 03-DEC-2009 11:29 AM Initiated by FDA? Yes
Telephone Number:

Communication Categorie(s):


Telecon Summary:
E-mail: Outstanding CMC issues and expected CMC PMC to date

FDA Participants: Julie Vaillancourt and Mike Smith

Non-FDA Participants: Jack Love and Carmel Devlin

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:


From: Vaillancourt, Julienne
Sent: Thursday, December 03, 2009 11:29 AM
To: 'Love Jack'; 'Devlin Carmel'
Cc: Smith, Michael (CBER)
Subject: document with outstanding CMC issues and expected CMC PMCs
Importance: High

Dear Jack and Carmel,

Please see attached document, which summarizes our outstanding CMC issues and expected CMC PMCs to date for BLA 125324. It is important for us to communicate the items listed on this document to you at this time. If time permits during our scheduled telecon at 12 noon today, we can discuss the additional items, beside the two issues on today’s telecon agenda. In particular, we expect to have some discussion with you on items 3, 4 and 6a, beside items 1 and 2, which we plan to discuss at 12 noon today. The other items on this document are expected PMCs as discussed on September 1, 2009.


Julienne Vaillancourt, R.Ph., M.P.H.
Captain, US Public Health Service
Regulatory Reviewer
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
US Food and Drug Administration

Phone: 301-827-5414

Fax: 301-827-3532

THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please immediately notify the sender immediately by e-mail or phone.


BLA 125324 Outstanding CMC Issues and Expected CMC PMCs

December 3, 2009

1. ----------(b)(4)---------------------------------------


2 pages determined not to be releasable; (b)(4)

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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