FDA publishes guidance on submission process for determining risk of investigational in vitro diagnostics

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

FDA has published a guidance for industry on an optional streamlined submission process for determining whether investigational in vitro diagnostic in clinical trials for an oncology therapeutic is considered significant risk, nonsignificant risk, or exempt from investigational device exemption requirements.

To access this subscriber-only content please log in or subscribe.

If your institution has a site license, log in with IP-login or register for a sponsored account.*
*Not all site licenses are enrolled in sponsored accounts.

Login Subscribe

YOU MAY BE INTERESTED IN

The long-awaited results from the RASolute 302 trial—a phase III clinical trial evaluating daraxonrasib, a RAS inhibitor, for the treatment of patients with previously treated, metastatic pancreatic ductal adenocarcinoma—have been read out. 
At a lecture at Yale Cancer Center recently, Robert A. Winn brandished a copy of a 32-year old booklet titled “Cancer at a Crossroads: A Report to Congress for the Nation,” using it as a show-and-tell prop in arguing that America’s cancer program is once again at a crossroads and therefore in urgent need of strategic thinking (The Cancer Letter, April 10, 2026).

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login