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FDA Advisory Committee Meeting Email (ctgtac roster), June 25, 2009 - Laviv

From:        Dapolito, Gail
Sent:          Thursday, June 25, 2009 3:38 PM
To:             Thomas, John; Tull, Lori
Subject:     FW: FDA Advisory Committee meeting
 
Attachments:    ctgtac roster.doc

 
FYI
 
______________________________________________
From:                     Dapolito, Gail 
Sent:                      Thursday, June 25, 2009 3:37 PM
To:                          'jnovak@cbrintl.com'
Subject:                 FDA Advisory Committee meeting
 
Dear Jeanne,
 
It was a pleasure speaking with you today about the upcoming Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) meeting.
 
The CTGTAC will meet on October 9. As soon as we get a venue, I will notify you.
 
Here is the link to the Guidance: Preparation and Public Availability of Information Given to Advisory Committee Member.
As I mentioned, the briefing documents (Isolagen's and FDA's) will be posted on the FDA website 48 hours prior to the meeting.
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125650.pdf
 
If Isolagen's document is fully releasable, it should be sent to me by Sept. 9. If not fully releasable the due date is August 11.
Please see the guidance for more details.
 
I will need approximately 35 copies of the briefing document. We will accept hard copies or CDs. If sending CDs, please also include 1 hard copy.
 
The agenda, questions, etc are a work in progress and I will follow-up as they are firmed up. The usual outline for the agenda is for the sponsor and FDA to have 60-90 minutes for presentation. 
 
If you would like to provide hard copies of slides to the Committee members (this is usually done as a courtesy as it helps the members in the discussion); please bring approx. 35 copies of slides to the meeting. It would be greatly appreciated if you would also share slides with FDA staff at least a week or so before the meeting.
 
I also attached the current CTGTAC roster. There are vacancies we are trying to fill before the meeting. I will notify you of any changes/new members to the roster.