CLIA, Regulatory, & Accreditation

|5 min read

FDA Takes Aim at Ensuring the Safety and Effectiveness of Laboratory Developed Tests

The FDA announced a final rule amending the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act
|5 min read

Mental Health Is Lab Health

What’s driving stress and burnout in the clinical lab—and how can the pressure be relieved?
Updated |3 min read

Selective PARP Inhibitor Improves Survival in Breast Cancer Trial

Saruparib has higher selectivity for PARP1, improving safety and tolerability compared to existing first-gen PARP inhibitors
Updated |3 min read

The State of Clinical Development in 2023

Increasing Phase 2 clinical trial cancellations can have a long-drawn and multifold impact on clinical research
|5 min read

The Far-Reaching Impact of Anti-LGBTQ+ Legislation

Laws that limit LGBTQ+ individuals’ rights and access to care place everyone’s health at risk
|2 min read

CDC Releases Guide to Address Healthcare Worker Burnout

The hospital-tested, evidence-based resource provides six steps to address and support mental health
Updated |2 min read

WHO Report Reveals Gender Inequalities in Health Systems

Work done primarily by women tends to be paid less and have poor working conditions
Updated |3 min read

Translating New Noninvasive Screening Methodologies to Clinical Practice

With biomarker research rapidly evolving, liquid biopsies are set to become the cornerstone of clinical cancer screening
|4 min read

Reducing Preanalytical Errors through Patient Education

How clinical labs can empower patients to minimize preanalytical errors
|2 min read

Typhoid Conjugate Vaccine Candidate Gets WHO Prequalification

Per the WHO, an estimated 11–20 million typhoid fever cases occur worldwide every year, resulting in 120,000–160,000 deaths
|2 min read

ACMG Recommends Deeper Research on PGT-P Safety, Efficacy

The College highlights the need for further studies to establish the clinical utility of polygenic risk scores in genetic testing
|2 min read

Empower Your Teams and Build Safer Workspaces

Listen, learn, and network with clinical industry giants at the 2024 Lab Manager Leadership Summit
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