[IGSTK-Developers] FDA talk at our center on Friday morning

Kevin Cleary cleary at georgetown.edu
Tue Jan 24 15:12:12 EST 2006


FYI

Let me know if there are specific questions you want me to ask

Kevin C.

-----Original Message-----
From: isis-core-owner at isis.imac.georgetown.edu
[mailto:isis-core-owner at isis.imac.georgetown.edu] On Behalf Of Katherine
Lawyer
Sent: Tuesday, January 24, 2006 2:15 PM
To: isis-core at isis.imac.georgetown.edu
Subject: Staff Meeting, Friday January 27th

Good afternoon everyone-

This is a reminder that there will be a staff meeting at 8:30am on Friday,
January 27th. The speaker this Friday will be Jim Callaghan of the FDA.  Jim
will talk about receiving FDA approval for software, however, he approaches
this from an In Vitro Diagnostic (IVD) and general premarket regulatory
requirements perspective.

A disclaimer from our guest "He is not be able to give opinions on specifics
outside of this area.  His talk will be considered an informal presentation
that represents his best judgment at this time but does not constitute an
advisory opinion, does not necessarily represent the formal position of FDA,
and does not bind or otherwise obligate or commit the agency to the view
expressed."

If anyone has anything else they would like to add to the agenda please let
me know. 

Also, right after the staff meeting the Secret Social Committee will be
meeting. Be sure to bring your disguise :)

Thanks,
Kay







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