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Vaccines

Record of Telephone Conversation - January 11, 2010 - Prevnar 13

System Info - 116636  SMITH, MICHAEL J  12-Jan-2010 11:23:14  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:  11-JAN-2010 11:27 AM               Initiated by FDA?  Yes
Telephone Number:

Communication Categorie(s):
Advice

Author:  MICHAEL SMITH

Telecon Summary:
Email: CMC PMC revision regarding the ----(b)(4)--- specification for serotype 1 from ------(b)(4)-----

FDA Participants:   Mike Smith, Julie Vaillancourt and Colleen Sweeney

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:                      Monday, January 11, 2010 11:27 AM
To:                          'Love Jack'; Devlin Carmel
Cc:                          Vaillancourt, Julienne; Sweeney, Colleen
Subject:                RE: CMC PMC's

Jack and Carmel,

CBER has agreed to your proposed CMC PMC revision regarding the ----(b)(4)----- specification for serotype 1 from -----(b)(4)------.

Mike

Mike Smith, Ph.D.
Lieutenant Commander (LCDR), U.S. Public Health Service
Regulatory Project Manager
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration

Phone:    301-827-9047
BB:         240-839-0823
Fax:        301-827-3532
E-mail:   michael.smith2@fda.hhs.gov

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End of email

 

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

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Building 71 Room 3103

Silver Spring, MD 20993-0002