(System Info - 107576 SHONE DEANNA 10/13/2009 17:20:57 SHONEDE)
RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA Submission ID: 125259/0 Office: OVRR
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
Telecon Date/Time: 07-Dec-2007 12:00 AM Initiated by FDA? Yes
1. Other - null
Author: MANETTE NIU
Clarification of Pharmacovigilance questions as per GSK request for
Trans-BLA Group : No
Related STNS :
Related PMCs :
Sent: Friday, December 07, 2007 2:02 PM
Subject: RE: CBER's Aug 21 Pharmacovigilance Comments - Clarification
Sorry for the delay in our reponse to you on this. Here is the response from Dr. Niu for your clarification of our August 21, 2007 request for information.
Please note that these are our initial comments. Depending on subsequent CBER evaluation & final labeling, CBER may request additions.
Response to #3a:
The agency is requesting VAERS forms (for domestic reports), and CIOMS forms (international reports for serious-expected, and non-serious-unexpected adverse event reports at each of these monthly periodic reports.
The agency is not specifically requesting nonserious-expected adverse event reports from outside the U.S. Please include as 15 day reports: All of the following adverse events whether or not they meet the regulation requirements for serious, including neuroinflammatory diseases (transverse myelitis, multiple sclerosis, optic neuritis, GBS), autoimmune diseases (rheumatoid arthritis, SLE), thrombotic events (deep venous thrombosis, pulmonary emboli), thrombocytopenia, seizure, syncope, spontaneous abortion, congenital birth defects (including ventricular septal defects).
As 30 day (monthly reports): All serious adverse events whether or not they meet the regulatio requirements for serious, including arthritis, arthralgia, arthropathy, proteinuria.
Response to #3d:
No further comments RE: Pregnancy registry.