News

JD Supra4d
Federal Court Blocks FDA’s Final Rule on LDTs: Key Considerations for Clinical Labs
The US District Court for the Eastern District of Texas issued a pivotal ruling in the consolidated lawsuit American Clinical Laboratory ...
Hosted on MSN23d
FDA simplifies rules governing use of popular acne medication isotretinoin
Acceptance of at-home pregnancy tests. The FDA now permits the use of at-home and non-Clinical Laboratory Improvement Amendments (CLIA) pregnancy tests, reducing the need for in-office visits ...
JD Supra10d
Post‑Chevron Spotlight: Federal Court Nixes FDA Rule Reclassifying Laboratory Services as Medical Devices
In another rebuke to federal regulatory overreach, the U.S. District Court for the Eastern District of Texas (“District Court ...
Business Insider India5y
Bankrupt poop-testing startup uBiome just lost the government approval that's required to run key tests
The CLIA rules stand for Clinical Laboratory Improvement Amendments and are designed to ensure that laboratories meet standards of cleanliness and reliability appropriate for healthcare.