FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
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
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.