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 inhibitorsUpdated |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 healthUpdated |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 conditionsUpdated |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















