Newsletter | June 11, 2024

06.11.24 -- What You Should Know About The FDA's New Final Rule On LDTs


What You Should Know About The FDA's New Final Rule On LDTs

The FDA made a small change with big consequences when it amended its definition of in vitro diagnostics. Here’s what it means for lab-developed tests.

FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies

This article provides a summary and analysis of the FDA's new draft guidance, Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products. The public comment period ends July 29.


Functional Fluidics Officially Opens Nigeria Clinical Research Center & Specialty Lab

Analytical Instrument Management Acquires PSI Laboratories' Assets

ARUP Files Declaration To Support Lawsuit Challenging The FDA's Rule To Regulate LDTs

Dobrobut Opened Own Diagnostic Laboratories In Kyiv

Kymanox Announces Facility Expansion To Enhance CGxP Space & Laboratory Service Offerings

Formosa Laboratories Completes The Acquisition Of Synchem To Expand NA CDMO Footprint

Nucleus Automation Partners Joins NVIDIA Inception Program

Medimab Biotherapeutics Opens Bespoke Laboratory Facilities At Abingdon Science Park, UK

IDEXX Expands Test Menu For The Catalyst Platform To Support Vets In Diagnosing Pancreatitis

Bruker Applied Mass Spectrometry Division Showcases High-Perf Solutions For Research & Analysis

TUV Rheinland's Northeast Tech & Innovation Center Receive Accreditation To Verify Equipment To Be Imported Into Korea