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Vaccines, Blood & Biologics

7/3/2007 Telecon - RECOTHROM

FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

Telecon

Date: July 3, 2007

To: File STN 125248/0 ZymoGenetics Thrombin (Recombinant)

From: Mark A. Shields, HFM-380; RPMB, DBA, OBRR, CBER; (301) 827-6173 FAX (301) 827-2857

Subject: 02-Jul-07 Telecon.

FDA Attendees: Mark Shields

ZymoGenetics Participants:
Dale Goodloe.

Discussion Points;

I called Mr. Goodloe to request he email me the names of the ZymoGenetics participants in the telecom held yesterday (02-Jul07). I also requested he submit their version of meeting minutes as an amendment to the BLA for the record.

He agreed to provide.

END

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