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
First Commercial Lab Gets FDA Emergency Clearance for Zika Test
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Culture-Independent Tests Gain Clinical Traction, Hamper Public Health
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U.S. Government Begins Prepping Battle Against Zika with National Summit
From - National Intelligence Report
With spring and mosquito season rapidly approaching, concern about and the fight against the Zika virus is heating up. Today, a press conference will be…
FDA Challenges DTC Genomic Tests from Startup Labs
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New FDA Approvals, Guidelines and Letters Address Zika Testing
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AACC Weighs in on Regulation of Laboratory Developed Tests
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FDA LDT Regulation Could Affect 60,000+ Tests
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ACLA Uses Cancer Initiative to Lobby on PAMA, LDTs
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Laboratory Data and Interoperability to be Focus of FDA Workshop
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