Gemignani, Helen S
From: Sullivan, Helen M
Sent: Friday, October 19, 2007 4:22 PM
Subject: RE: Cervarix - August 21 Pharmacovigilance Comments
From: Matt.Whitman@gsk.com [mailto:Matt.Whitman@gsk.com]
Sent: Friday, October 19, 2007 4:15 PM
To: Sullivan, Helen M
Subject: Re: Cervarix - August 21 Pharmacovigilance Comments
Hi Helen - can we please get clarification on the following? Thanks Matt
3. In regard to Routine Pharmacovigilance, we have the following comments:
a. For the first three years following vaccine licensure, we request that you provide FDA with monthly
batches of all adverse event reports not included among the serious and unexpected (15-day) reports
received by GSK. Also, we recommend that you include all available follow-up information obtained from
(“obtained for” instead of “obtained from”?) previous adverse event reports in these monthly batches.
GSK requests clarification of the following:
Is the Agency requesting line-listings, or CIOMS 1 (foreign reports) and VAERS forms (for domestic reports),
for serious-expected and nonserious-unexpected adverse event reports at each of these monthly periodic reports?
Is the Agency also requesting nonserious-expected adverse event reports from outside of the US?
GSK agrees with the submission of monthly periodic reports and proposes that the time frames and schedule for the reports be discussed and agreed with the Agency. For example, one proposal would be that each report be submitted on the first business day of the month, and include reports and follow-up received during the 30-day period ending on the 15th of the previous month (e.g., the June 1 report would include data received from April 15 though May 15).
d. Regarding the pregnancy registry, please consider addressing elements in the Guidance for Industry:
Establishing Pregnancy Exposure Registries (9/20/2002)
The FDA Guidance was considered when the Pregnancy Registry protocol was drafted. Are there specific
elements of the Guidance document or of the draft protocol that the FDA would like for GSK to consider adding to the Pregnancy Register?
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Vaccines, Blood & Biologics
Gemignani, Helen S