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Vaccines

Record of Telephone Conversation - May 1, 2009-1 - Prevnar 13

System Info - 113387  SMITH, MICHAEL J  10-Dec-2009 10:29:10  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:  01-MAY-2009 02:30 PM              Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Information Request

Author:  MICHAEL SMITH

Telecon Summary:
RE: Email IR for 5 SOPs

FDA Participants:   Mike Smith and Julie Vaillancourt

Non-FDA Participants:    Jack Love and Carmel Devlin

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:
______________________________________________
From:                     Smith, Michael (CBER) 
Sent:                      Friday, May 01, 2009 2:31 PM
To:                          'LOVEJ@wyeth.com'; 'DEVLINC@wyeth.com'
Cc:                          Vaillancourt, Julienne
Subject:                RE: Request for additional documents for BLA 125324

Jack and Carmel,

    I have an additional list of documents to request, please submit these documents to the BLA as an amendment.

1. Detailed SOPs for all serotype Pneumococcal Activation Processes.

2. Detailed SOPs for ------(b)(4)---- and Reconstitution for all serotypes.

3. Detailed SOPs for Conjugation Reaction for all serotypes.

4. Detailed SOPs for -----------(b)(4)------ impurity removal for all serotypes.

5. Detailed SOPs for ------------(b)(4)------ impurity removal for all serotypes.

Thank you,

Mike

End of email.

 

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