System Info - 107180 SHONE, DEANNA 07-Oct-2009 14:25:51 SHONEDE
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125259/0 Office: OVRR
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
Telecon Date/Time: 30-SEP-2009 05:03 PM Initiated by FDA? Yes
Author: MICHAEL NGUYEN
Postmarketing Comments Follow Up and Request for Additional Information
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Sent: Wednesday, September 30, 2009 5:03 PM
Cc: 'email@example.com'; 'Cynthia.A.D'Ambrosio@gsk.com'
Subject: RE: Cervarix - Postmarketing Comments Follow Up and Request for Additional Information
The following items are in regard to the MCO Phase IV study. In the interest of time, please respond via email with a follow up amendment to the BLA:
1) Please submit to us the actual or projected dates, as per 21 CFR 601.70(7), for the following:
- Date of Submission of Protocol
- Completion of Patient Accrual
- Submission of Annual Interim PMC Study Reports
- Completion of the Study
- Date of Submission of the Final Study Report
2) Please submit a brief response to each item in the September 16, 2009, Information Request (see below).
3) Please consider exchanging the pregnancy registry component of the PMC, with participation in VAMPSS (Vaccines and Medications in Pregnancy Surveillance System). VAMPSS uses both prospective surveillance and case control methods and is coordinated by the American Academy of Allergy, Asthma and Immunology.