District Court Overturns FDA’s LDT Rule: What the Ruling Means for Clinical Labs Now
Christine P. Bump
Under the district court’s vacatur, the LDT final rule and its compliance deadlines are no longer in effect and cannot be enforced
FDA
Pause in Federal Health Communications Should Concern Clinical Lab Workers
Scott Wallask, BA
Clinical lab veterans and newcomers have reason to monitor the shutdown of information from the Trump administration
Revvity Announces FDA Clearance for First Automated Free Testosterone Test
Revvity
This innovative test is the first of its kind to receive FDA clearance for direct quantitative measurement of free testosterone levels
Will President-Elect Donald Trump Change the FDA’s LDT Final Rule?
Scott Wallask, BA
Clinical labs eager for relief from upcoming FDA compliance dates are looking to the new presidential administration
Initial Crowdfunding Assays Are Now Available in Response to LDT Final Rule
LISAbio
LISA heads up new effort with UTI assays designed to comply with the FDA’s regulations for lab-developed tests
FDA, CLIA, and ISO—Which Regulations Apply to Your Clinical Lab?
Michael Schubert, PhD
Experts Julie Ballard and Lindsay Strotman help you navigate the complexities of FDA, CLIA, and ISO standards for the clinical lab
First Ever Effort to Crowdfund Diagnostic Assays Launches in Response to FDA LDT Final Rule
LISAbio
LISA CEO explains why crowdfunding is a viable way to shoulder the new regulatory costs behind laboratory-developed tests
Crowdfunding Solutions for CAP/COLA Labs to Overcome FDA LDT Rule Costs
LISAbio
Learn how clinical labs can leverage crowdfunding to reduce diagnostic test development costs and meet FDA LDT compliance requirements
What Clinical Labs Creating LDTs Need to Know About the U.S. FDA Final Rule
DNA Genotek
A Strategic Guide for Clinical Labs to Stay Compliant and Thrive Amid Regulatory Changes
Navigating FDA’s LDT Final Rule: Key Terminology Every Clinical Lab Should Know
Shannon Bennett, MS, MBA
As the first milestone of the new LDT Final Rule approaches, here are the key FDA terms laboratories need to understand