EU IVDR 2017/746: Impact to Clinical Laboratories and Drug Developers
David Latto, PhD, Jill Haizlip, BS, MBA
How central labs can mitigate IVDR impact
Compliance
Ensuring Precision in Dose Accuracy Verification
Today's Clinical Lab
Solutions for mitigating error and improving precision in dose accuracy testing
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, 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
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
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
The Quiet Brilliance of Efficient Water Purification
ELGA
Impeccable Water Purification Systems Power the Lab With Minimal Staff Interaction
Top 3 Tips: Implementing Robust Quality Control Protocols to Prevent Errors
INTEGRA
Three tips for implementing robust quality control protocols and procedures to prevent errors and ensure patient well-being
Trio of Lawmakers Introduces Resolution to Repeal FDA Final Rule on LDTs
Rep. Brad Finstad
Reps. Finstad and Crenshaw, Sen. Paul introduce a resolution under the Congressional Review Act to repeal harmful FDA rule limiting access to laboratory-developed tests