Coronary Drug Eluting Stents Non-clinical and Clinical Studies

AdvaMed/FDA Workshop
April 29, 2008

Guidance for Industry: Coronary Drug-Eluting Stents—Non-clinical and Clinical Studies 

(ADVISORY: Registration has CLOSED)

The purpose of this AdvaMed/FDA co-sponsored workshop is to clarify recommendations provided in the March 2008 FDA draft guidance (Guidance for Industry: Coronary Drug-Eluting Stents—Non-clinical and Clinical Studies)

Location:

FDA White Oak Campus
Room 2047
Central Shared Use Building (Building 2)
10903 New Hampshire Avenue
Silver Spring, MD 20993

DATE:

April 29, 2008

TIME:

8:00 am to 6:00 pm EDT

Registration:

Rates:
$125 Non-government
$75   Government

Click here to register. (**Note: registration for this event has CLOSED.)

SECURITY:

Please plan your arrival to allow time for security processing.

All attendees must provide government issued identification (with photograph), e.g., passport, driver’s license. Cameras or other recording equipment are not permitted through security. FDA personnel will be available to escort you from the security checkpoint to the workshop.

Non-U.S. citizens must complete a Foreign National Visitor Request form. Email (srobertson@advamed.org) or fax (202-783-8750 attention: S. Robertson) completed forms no later than April 11, 2008.

TRAVEL INFORMATION:

Click here for information on airports, hotels, transportation, and parking.

AGENDA:

Click here to view draft agenda.

FDA speakers will discuss those sections of the draft guidance about which workshop participants have questions. Industry representatives will participate in panel discussions to aid in clarification.