Take Care In Promoting Lab-Developed Genetic Tests Or Risk US FDA, FTC Ire
Executive Summary
Device-practice attorneys provide tips and precautions for laboratories advertising and promoting non-cleared or unapproved molecular-based diagnostics, and avoiding enforcement.
You may also be interested in...
More DTC Gene Test Firms Hit With FDA Untitled Letters
FDA recently sent untitled letters to three direct-to-consumer genetic testing firms asking them to seek clearance for their making medical claims.
Clinical Labs Lawyer Up In Battle Over LDTs
ACLA has recruited Laurence Tribe and Paul Clement, two prominent constitutional legal guns with Supreme Court expertise, to fight FDA over its proposed lab-developed test guidance. The announcement is perhaps the lab industry's most high profile move yet to oppose FDA's plan to regulate lab-developed test services under the device statute with a risk-based phase-in plan.
White House To Deliver 25 Million Face Masks To Low-Income Americans
The White House will be spending $86m to provide tens of millions of coronavirus masks to poorer American households.