FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
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Expanding Test Menus: A Compliance Roadmap for FDA-Regulated Labs
Two OIG advisory opinions guide laboratories that want to work with pharma or medical device companies on expanded testing
HHS Suddenly Dismantles CLIAC After 33 Years
The board was eliminated as part of a sweeping reordering of the Department of Health and Human Services
FDA Synthesizes Feedback on LDTs in New Discussion Paper
From - National Intelligence Report
Following up its decision not to issue final guidance in 2016 regarding oversight of laboratory developed tests (LDTs), the U.S. Food and Drug Administration released a…
FDA Won’t Release Final LDT Guidance in 2016
From - National Intelligence Report
The U.S. Food and Drug Administration (FDA) has provided laboratories with some much needed good news—the agency will not finalize its…
CDC and the Diagnostics Industry Continue to Battle Zika
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FDA Recommendation Against Ovarian Cancer Screening
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FDA Considers Liquid Biopsies
From - National Intelligence Report
In addition to laboratory developed tests and next generation sequencing, could the FDA be looking to impose standards or guidance governing use of…
Public Comment Sought on Blood Donor Deferral Policies to Reduce HIV Transmission
From - National Intelligence Report
While the annual rate of new diagnosed cases has declined in the last 10 years, HIV still remains a significant concern. The Centers for Disease Control and Prevention (CDC) reports…
FDA Holds Exploratory Meeting on Liquid Biopsies
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FDA Issues Draft Guidelines for Companion Diagnostics
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