The purpose of the workshop is to facilitate an in-depth discussion of harmonization of companion diagnostic devices across a class of targeted therapies. The workshop aims to foster collaborations in the clinical cancer research community; provide a deeper understanding of anticancer drug and device development related to personalized medicine; provide a unique perspective of personalized medicine; and help incorporate emerging scientific findings to harmonize companion diagnostics across a class of targeted therapies.
- Date, Time and Location
- Federal Register
- Agenda
- Registration (In-Person and Audiocast)
- Comments
- Contact Us
Date, Time and Location:
This meeting will be held March 24, 2015, beginning at 8:30 a.m. at the following location:
Mayflower Hotel
Grand Ballroom
1127 Connecticut Avenue, NW
Washington, DC 20036
(202) 347-3000
Agenda
The agenda will be posted soon.
Registration to Attend the Workshop:
To register for the public workshop, please visit the following Web site: https://www.surveymonkey.com/s/FDACompanionDiagnostics2015
Streaming Live Audiocast
To register for the streaming live audiocast, please use the following Web site: https://www.surveymonkey.com/s/FDACompanionDiagnostics2015
Comments
FDA is holding this public workshop to obtain information on harmonization of companion diagnostics across a class of targeted therapies. To permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop. The deadline for submitting comments related to this public workshop is April 23, 2015.
Regardless of attendance at the public workshop, interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document.
[email protected];
Pamela Bradley, Center for Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-731-3734, [email protected];
Rasika Kalamegham, American Association for Cancer Research, 1425 K St. NW., Washington, DC 20005, 267-765-1029, [email protected].
If you need special accommodations due to a disability, please contact Kaitlyn Antonelli (see Contact Persons), 571-483-1606, [email protected], no later than March 10, 2015.