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Vaccines

Record of Telephone Conversation - Cervarix, October 7, 2009

System Info - 107808  SHONE, DEANNA   15-Oct-2009 10:12:38  SHONEDE

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125259/0    Office: OVRR  

Product:

Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant

Applicant:                                                                       

GlaxoSmithKline Biologicals          

Telecon Date/Time:  07-OCT-2009 02:30 PM                Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Information Request

Author:  LORI AUSTIN-HANSBERRY

Telecon Summary:

Postmarketing Comments Follow Up and Request for Additional Information

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:


 

From: Austin-Hansberry, Lori
Sent: Wednesday, October 07, 2009 2:30 PM
To: 'Matt.Whitman@gsk.com'
Cc: Nguyen, Michael D.; Sutherland, Andrea
Subject: FW: RE: Cervarix - Postmarketing Comments Follow Up and Request for Additional Information

Dear Mr. Whitman:

Please provide the following additional information:  (a) study start and completion date and sample-size calculations (number of pregnancies, duration of study, and/or relative risk target) for the pregnancy registry and (b) an agreement to provide annual interim reports to be submitted within 3 months of the yearly-cut off date for both the PMC on autoimmune diseases and the pregnancy registry.

Regards,

Lori Austin-Hansberry, MSA, BSN

CDR, U. S. Public Health Service

Sr. Regulatory Project Manager, FDA/CBER/OBE/DE

1401 Rockville Pike, Rm 434S, HFM-220

Rockville, MD 20852-1448

LJA@fda.hhs.gov

Office: 301-827-6048

Fax: 301-827-5218