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
FDA
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
FDA Predetermined Change Control Plans May Aid LDT Modifications
Karin Hughes, PhD
A new PCCP draft guidance outlines what elements the agency expects in these plans
Syphilis Assay Is Now Available on VITROS 3600, 5600, and 7600 Systems in the US
QuidelOrtho
There’s been a 36 percent increase in cases of primary and secondary syphilis since 2021
Webinar Recap: LDT Compliance Requirements for FDA Final Rule
Christine P. Bump
Christine P. Bump shares key insights from the FDA’s August 22 webinar on LDTs compliance