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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
Human Papillomavirus Vaccine, AS04 Adjuvant-Adsorbed
Telecon Date/Time: 01-APR-2009 12:00 AM Initiated by FDA? Yes
Author: HELEN GEMIGNANI
Information Request for PREA
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Gemignani, Helen S
Sent: Wednesday, April 01, 2009 6:43 PM
Cc: 'Cynthia.A.D'Ambrosio@gsk.com'; 'firstname.lastname@example.org'
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
Division of Vaccines and Related Products Applications/Viral Vaccine Branch