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 Watch: Agency Approves New Flu Tests and Drug
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FDA Biological Products Agency Issues New Recommendations for Emergency Weather Response
From - National Intelligence Report
With another hurricane season wreaking havoc, the FDA's Center for Biologics Evaluation and Research (CBER), which regulates…
LDTs: FDA Does an End Run on Regulatory Proposal Lab Industry Helped Create
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New Zika Blood Testing Guidance Effective Immediately
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FDA Says LOINC Coding of IVD Tests Is Voluntary, Not Mandatory
From - National Intelligence Report
On June 15, the FDA issued a new guidance document clarifying the rules for laboratory coding of in vitro diagnostic tests. There are four…
Genomic Tests: Two New Assays Win FDA Breakthrough Device Designation
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New FDA Guidance Aims to Ease Approval for New NGS Tests—But It Probably Won’t Work
From - National Intelligence Report
Test makers have long complained about the FDA's unwillingness to embrace technology and diagnostics advances. But on April 13, the agency took steps to address…
Case of the Month: $33.2 Million Alere Settlement Sends Warning Shot Across Bow of LDT & DX Device Makers
From - National Intelligence Report
One of the reasons Abbott Laboratories got cold feet about consummating the $5.3 billion Alere acquisition was concern over the legal proceedings against the…
FDA Watch: Agency Approves DTC Genetic Breast Cancer Test—But Attaches Strings
From - National Intelligence Report
On March 6, the FDA announced its first ever approval of a direct-to-consumer breast cancer gene test…