Tuesday, November 21, 2023

FDA Holds Panel on Multi Cancer Early Detection: November 29, 2023

On Wednesday, November 29, 2023, FDA will hold a molecular advisory panel on the topic of Multi Cancer Early Detection.  Here's a clipping:

  • On November 29, 2023, 9-5 ET, the Molecular and Clinical Genetics Panel will discuss and make recommendations on the design of multi-cancer detection (MCD) in vitro diagnostic devices (tests) as well as potential study designs and study outcomes of interest that could inform the assessment of the probable benefits and risks of MCD screening tests. The committee’s discussion and recommendations from this meeting will help inform future Agency regulatory efforts for these novel tests.
  • FDA intends to make background material available to the public no later than 2 business days before the meeting.  NOTE: POSTED BY NOV 28; KEY QUESTIONS; 10 P BACKGROUND.
  • The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

The web page is here:

https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-29-2023-molecular-and-clinical-genetics-panel-medical-devices-advisory-committee-meeting

The page includes a Webcast Link.

See FED REG and comments submission portal:

https://www.federalregister.gov/documents/2023/11/13/2023-24896/molecular-and-clinical-genetics-panel-of-the-medical-devices-advisory-committee-notice-of-meeting

It's published as 88 Fed Reg 77588-90, November 13, 2023.

Check yourself for updates but the YouTube link appears to be:

https://youtu.be/xyOrADJQj4U