7/3/2007 Telecon - RECOTHROM
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|
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.