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Vaccines

Record of Telephone Conversation - Cervarix, April 1, 2009

System Info - 94803  SHONE, DEANNA   21-May-2009 14:07:00  SHONEDE

RECORD OF TELEPHONE CONVERSATION

 

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

Product:

Human Papillomavirus Vaccine, AS04 Adjuvant-Adsorbed

Applicant:                                                                       

GlaxoSmithKline Biologicals          

Telecon Date/Time:  01-APR-2009 12:00 AM               Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Information Request

Author:  HELEN GEMIGNANI

Telecon Summary:

Information Request for PREA

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

From: Gemignani, Helen S
Sent: Wednesday, April 01, 2009 6:43 PM
To: 'Matt.Whitman@gsk.com'
Cc: 'Cynthia.A.D'Ambrosio@gsk.com'; 'nicholas.perombelon@gsk.com'
Subject: Cervarix - PREA Request

The Pediatric Research Equity Act of 2007 (Title IV of the Food and Drug Administration Amendments Act of 2007) was passed in September 2007. This law was enacted after the date of the submission of the original BLA. Please review your original submission and, if necessary, submit a revised proposal for pediatric studies based on Section 505B [355c] of the Federal Food, Drug and Cosmetic Act (Research into Pediatric Uses for Drugs and Biological Products) by April 30, 2009, as an amendment to your BLA.

Please refer to the following FDA Guidance for Industry entitled "How to Comply with the Pediatric Research Equity Act": http://www.fda.gov/cber/gdlns/pedreseq.htm

Feel free to contact me if you have any questions.

Helen Sullivan Gemignani
Regulatory Project Manager
FDA/CBER/OVRR
Division of Vaccines and Related Products Applications/Viral Vaccine Branch
(301) 827-3070