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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation - Cervarix, December 11, 2007

(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

Product:                     

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

Applicant:                   

GlaxoSmithKline Biologicals  

 Telecon Date/Time:  11-Dec-2007 12:00 AM            Initiated by FDA? Yes                                           

Telephone Number:                                                                      

Communication Categorie(s):                              

1. Advice                                             

Author:                     MANETTE NIU

Brief Description:           

Clarification of 08/21/07 Pharmacovigilance Comments

FDA Participants:            

Non-FDA Participant(s):      

Trans-BLA Group :                 No                           

Related STNS :               

Related PMCs :               

Telecon Body:                

Sent: Tuesday, December 11, 2007 1:03 PM

To: 'Sharon.W.Shapowal@gsk.com'

Cc: 'Matt.Whitman@gsk.com'

Subject: RE: CBER's Aug 21 Pharmacovigilance Comments - Clarification

Sharon,

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.