Diagnostics Pipeline: Testing for Intestinal Parasites Takes Step Forward
The EasyScreen assay received 510(k) clearance from the Food and Drug Administration earlier this year–but with a catch
FDA-dtet
Evolving Regulations and Guidelines in Genetic Testing
Understanding the regulatory landscape of genetic and genomic testing, and its impact on clinical practice
Esophageal Pre-Cancer Testing Gaining Greater Traction
How three companies are addressing screening challenges with tests that help improve chances of early detection
FDA Greenlights Assays Using New Test Model for Lyme Disease Diagnosis
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Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory
FDA Issues Warning for ‘Over Reliance’ on Rupture of Membrane Tests
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FDA Considering Self-Collection Sample Regulation
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FDA Medical Device User Fees Rise as Part of Reauthorization
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Kellison Award goes to FDA’s Dr. Alberto Gutierrez
From - Laboratory Industry Report
Dr. Alberto Gutierrez is the 2017 recipient of the Kellison Lab Industry Distinguished Service Award. Dr. Guitierrez retired in August after…
FDA Reports Progress in Advancing Regulatory Science for Diagnostics
From - Diagnostic Testing & Emerging Technologies
The U.S. Food and Drug Administration (FDA) recently unveiled its FY 2015-2016: Regulatory Science Progress Report. The report, the second of its kind under the…
FDA Speeding Approval Process, Continued User Fees Needed
From - Diagnostic Testing & Emerging Technologies
The U.S. Food and Drug Administration (FDA) is plagued with chronic understaffing, scrutiny over the length of time for approvals, and an expanding workload, while also…
Testing Recommendations Expand as Zika Season Approaches
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FDA Approves First-Ever, Pan-Cancer Drug in Milestone for Personalized Medicine
From - Diagnostic Testing & Emerging Technologies
In what is being heralded a major milestone for personalized medicine, in late May the U.S. Food and Drug Administration (FDA) approved the first…