Quasar FDA Phase I Implementation kit Available! At Quasar Instruments, we understand the challenges laboratories face when navigating FDA Laboratory […]
FDA LDT Phase 1 Implementation: A Practical Approach Read Post »
A Growing Threat: What Are Nitazenes? Nitazenes are a new and highly potent class of synthetic opioids that have rapidly
Denver, CO – July 7, 2025 The recently passed “One Big Beautiful Bill Act” (OBBBA) introduces broad changes to federal
2025 Federal Budget Signals Change—But Toxicology Remains Vital Read Post »
🔍 Quasar’s Perspective on the FDA’s Phased LDT Framework At Quasar Instruments, we’ve been closely following the FDA’s proposed framework for
Quasar’s Perspective on the FDA’s Phased LDT Framework Read Post »
Background of the Ruling On March 31, 2025, a federal judge vacated the FDA’s final rule that would have subjected
Summary of FDA LDT Court Ruling and Implications Read Post »
Industry Concerns Amid Regulatory Uncertainty As the May 6, 2025, implementation date for Phase One of the FDA’s LDT Final
Regulatory Shake-Up: FDA’s LDT Final Rule Faces Legal Battles & Industry Uncertainty Read Post »
The U.S. FDA has finalized its rule on Laboratory Developed Tests (LDTs), subjecting LDTs to regulatory requirements similar to other
FDA LDT Compliance & Quasar’s Phase I Implementation Read Post »
FDA’s Lab-Developed Test Rule: Will New Leadership Bring Change? The clinical lab industry is watching closely to see if President
Will the Trump Administration Change the FDA’s LDT Rule? Read Post »
The Association for Diagnostics and Laboratory Medicine (ADLM) is actively advocating against the FDA’s recent regulation of laboratory-developed tests (LDTs),
Laboratory Developed Tests | FDA contains background information, phaseout policies, FAQs and resources including webinars related to the final ruling. Definitions
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