Record of Telephone Conversation - Cervarix, September 30, 2009

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  

Product:

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

Applicant:                                                                       

GlaxoSmithKline Biologicals          

Telecon Date/Time:  30-SEP-2009 05:03 PM     Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Information Request

Author:  MICHAEL NGUYEN

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:

---

 

Sent: Wednesday, September 30, 2009 5:03 PM
To: 'Matt.Whitman@gsk.com'
Cc: 'nicholas.perombelon@gskbio.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.