CLIA, Regulatory, & Accreditation

|5+ min read

FDA, CLIA, and ISO—Which Regulations Apply to Your Clinical Lab?

Experts Julie Ballard and Lindsay Strotman help you navigate the complexities of FDA, CLIA, and ISO standards for the clinical lab
|1 min read

Stay Competitive in a Fast-Paced Environment by Addressing Key Operational Barriers

Implementing solutions to improve turnaround time, sample traceability, fragmented data, and regulatory issues can help labs better meet industry standards
Sponsored by
|3 min read

First Ever Effort to Crowdfund Diagnostic Assays Launches in Response to FDA LDT Final Rule

LISA CEO explains why crowdfunding is a viable way to shoulder the new regulatory costs behind laboratory-developed tests
Sponsored by
|1 min read

Crowdfunding Solutions for CAP/COLA Labs to Overcome FDA LDT Rule Costs

Learn how clinical labs can leverage crowdfunding to reduce diagnostic test development costs and meet FDA LDT compliance requirements
Sponsored by
|2 min read

What Clinical Labs Creating LDTs Need to Know About the U.S. FDA Final Rule

A Strategic Guide for Clinical Labs to Stay Compliant and Thrive Amid Regulatory Changes
Sponsored by
|2 min read

PAMA Cuts Averted Again for Clinical Lab Services

ACLA applauds congressional action to delay Medicare decreases and urges long-term reform
|2 min read

CRDSA Announces New Standards for Clinical Trial Data Reuse

The new standards aim to facilitate responsible sharing and use of anonymized individual patient data from clinical studies to support research and accelerate the discovery and delivery of new therapies
|1 min read

Maximize Lab Operations with an Efficient Water Purification System

Improve patient care with laboratory water systems–reducing maintenance burdens, and ensuring reliable test results
|3 min read

Navigating FDA’s LDT Final Rule: Key Terminology Every Clinical Lab Should Know

As the first milestone of the new LDT Final Rule approaches, here are the key FDA terms laboratories need to understand
|4 min read

Improving Indoor Air Quality in Clinical Laboratories: Best Practices for Safety and Compliance 

A guide to indoor air quality in the clinical lab—understanding the hazards, monitoring risk, and taking action to prevent issues
|1 min read

Improve Experimental Efficiency with Advanced Water Purification

Integrated high-purity water systems can enhance accuracy, reduce downtime, and optimize workflows
Sponsored by
|2 min read

Agilent Unveils Biopharma CDx Services Lab to Accelerate Precision Medicine

New CLIA-certified lab ensures seamless transition from early assay development and testing to full companion diagnostics commercialization
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