Public Workshop on Minimal Residual Disease (MRD) as a Surrogate Endpoint in Acute Myeloid Leukemia (AML)

The Food and Drug Administration (FDA) is announcing a public workshop to provide a forum to discuss whether currently available information support the use of the biomarker minimal residual disease (MRD) in Acute Myeloid Leukemia (AML) as a surrogate endpoint in evaluating new drugs for the treatment of the disease.

Date:            March 4, 2013

Time:            8:00 a.m. to 4:00 p.m.

Location:     FDA White Oak Campus
                      10903 New Hampshire Avenue,
                      Bldg. 31, Room 1503
                      Silver Spring, Maryland 20993

• Federal Register Notice
• Agenda (PDF - 16KB)
• Meeting Roster (PDF - 29KB)
• Transcript: Monday, March 4, 2013 (PDF - 532KB)

Meeting Information on MRD in ALL held on April 18, 2012

• Public Workshop on Minimal Residual Disease (http://www.fda.gov/Drugs/NewsEvents/ucm294931.htm)

Webcast of the Meeting

For those unable to attend in person, the meeting will also be webcast. Watch the webcast on February 27, 2013 from 8:00 am to 4:00 pm. Requirements and instructions for accessing the webcast are below.

Meeting Recordings

• https://collaboration.fda.gov/p89183585/
• https://collaboration.fda.gov/p19366535/
• https://collaboration.fda.gov/p47775109/

You may access the webcast via this link:
https://collaboration.fda.gov/amlworkshop/

Adobe Connect Minimum Requirements:

• View meetings on Windows, Macs, Unix, and Linux platforms
• Lan or Broadband internet connection
• Supports Internet Explorer, Firefox, Safari, Netscape Navigator, AOL
• Adobe Flash Player (no other downloads needed)
• VPN and Parachute compatible but not required
• Test my computer for Adobe Connect-Readiness

Vistor Information

All meeting attendees must enter through Building 1 on the FDA White Oak Campus. Parking is available in the Southeast surface lot and a shuttle bus will be available to bring attendees from the lot to Building 1. Please see Directions/Transportation/Parking/Hotels for the FDA White Oak Campus (PDF - 115KB) for directions and further details about transportation and lodging.

Here is a map of the campus Map of White Oak Visitor Parking (PDF - 105KB)

Lunch and Refreshments

Coffee, water, and light snacks will be available for a nominal fee starting at 7:15 a.m., again at 9:45, and for a final time at 2:20 p.m. 

Salads and sandwiches will also be available for purchase during the lunch break at 12:05.

Registration Information

There is no registration fee for the public workshop. To register electronically, please use the following website:

•  http://www.zoomerang.com/Survey/WEB22GPAXN9NQB 

For Further Information Contact

Christine Lincoln, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903, 301-796-4117, Christine.Lincoln@fda.hhs.gov