JD Supra

FDA Sued Over Laboratory Developed Tests Final Rule

The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed Tests (LDTs). The Final Rule requires laboratories to adhere to the same ...
JD Supra

FDA’s Authority Over Lab-Developed Tests Overturned: What the Court’s Decision Means for Lab Testing

Previously, this blog covered the FDA’s decision to regulate lab-developed tests (LDTs) as medical devices. However, a ruling from a federal district court in Texas earlier this year has changed that.
Medscape

FDA Faces Blowback Over Stricter Regulation of Lab-Developed Tests

The US Food and Drug Administration (FDA) plans to scrutinize the safety and efficacy of lab-developed tests — those designed, manufactured, and used in a single laboratory — far more thoroughly in ...
Kotaku

Touhou Koujoukaku: Over the Developed Eden

All the Latest Game Footage and Images from Touhou Koujoukaku: Over the Developed Eden Touhou fangame developed by Rodori. Games metadata is powered by IGDB.com Starfield‘s Next Big Update Isn’t A 2.0 ...