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

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

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: 03-DEC-2009 11:29 AM Initiated by FDA? Yes
 Telephone Number: 

Communication Categorie(s):
 Other

Author: JULIENNE VAILLANCOURT

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:

E-mail:


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 todays 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.

Julie

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
 E-mail: julienne.vaillancourt@fda.hhs.gov

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Attachment:

BLA 125324 Outstanding CMC Issues and Expected CMC PMCs

December 3, 2009

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