From: Thomas.Guinter@sanofi-synthelabo.com
Sent: Thursday, May 29, 2003 3:13 PM
To: fdadockets@oc.fda.gov
Cc: Larry.Rodman@sanofi-synthelabo.com
Subject: Docket Number 02N-0532


Sanofi-Synthelabo would like to be considered for participation in the
Nonclinical datasets pilot.  We have demonstrated our qualifications
through NDA, sNDA and BLA submissions in compliance with the FDA's eSUB
guidance published in January 1999 as well as our participation in CDISC
and Nonclinical standards activities.  Specifically we have:

      Submitted 1,716 electronic data sets for both clinical and pk data
      for 70 studies across 4 NDAs, 2 sNDAs, 1 BLA and 2 NDA amendments in
      compliance with the FDA's eSUB guidance

      Been a CDISC Corporate Sponsor since late 2000

      Attended all CDISC IAB meetings since late 2000

      Attended all US DIA Data Standards conferences where CDISC was a
      topic since 2000

      Participated actively in the CDISC SDS since March, 2002

      Implemented CDISC SDM V2.0 internally for all new projects as of
      June, 2002

      Posted our internal Safety Database standard (based on CDISC SDM
      V2.0) on the CDISC Clinical Standards Forum in October, 2002

      Participated actively in the ILSI Nonclinical/Clinical Correlation
      Committee.

      Participated in the Nonclinical standards industry working group


Our contacts will be:

Larry Rodman
Sr. Toxicologist
Larry.Rodman@Sanofi-Synthelabo.com
(610) 889-6397

Thomas Guinter
Sr. Manager Electronic Submissions
Thomas.Guinter@Sanofi-Synthelabo.com
(610) 889-6517

Sanofi-Synthelabo Research
9 Great Valley Parkway
Malvern, PA  19355