(System Info - 107579 SHONE DEANNA 10/13/2009 17:25:23 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: 11-Dec-2007 12:00 AM Initiated by FDA? Yes
Author: MANETTE NIU
Clarification of 08/21/07 Pharmacovigilance Comments
Trans-BLA Group : No
Related STNS :
Related PMCs :
Sent: Tuesday, December 11, 2007 1:03 PM
Subject: RE: CBER's Aug 21 Pharmacovigilance Comments - Clarification
This sentence does read must better. I hope this helps to clarify your question.
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 othese 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 adverse event reports of arthritis, arthralgia, arthropathy, proteinuria whether or not they meet the regulation requirements for serious.