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 Clears the Way for Approval of Blood-Based PSA Test
The U.S. Preventive Services Task Force (USPTF) recommends that men age 55 to 65 consider prostate cancer screening. The reason it doesn’t directly recommend testing for all men in this age group is that current screening methods that rely on detecting high levels of
FDA Watch: New Process for Simultaneous Review IVD Tests Used in Cancer Drug Trials
Typically, in vitro diagnostic (IVDs) tests used in investigational cancer drug trials require two submissions: one for the IVD test and another for the drug. But on Oct. 9, the FDA issued final guidance allowing companies to submit for simultaneous review for the clinical trial.
FDA Watch: New NGS Data Guidance May Ease Antiviral Drugs & Companion Test Approvals
A new FDA Technical Specifications document (Tech Doc) lists recommendations for sponsors on use of next generation sequencing data to secure approval of new antiviral drugs and related diagnostic tests providing crucial guidance on six key issues.
FDA Watch: Agency Okays EIA Technology-Based Lyme Assays
From - Laboratory Industry Report
Laboratory diagnosis of Lyme disease is based on detecting the presence of antibodies against…
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FDA Watch: First Zika Assay Gets Green Light for Marketing
From - Laboratory Industry Report
Over the past several years, the FDA has issued Emergency Use Authorization (EUA) for over a dozen different tests for…
FDA Watch: Agency Approves New STD Screening Assay Applications
From - Laboratory Industry Report
The FDA broke new ground by clearing a pair of STD screening assays for detecting chlamydia and gonorrhea for use with extragenital specimens, specifically from the…
FDA Watch: New Warning Letter May Signal Resurgence of LDT Enforcement Activity
From - Laboratory Industry Report
After a couple of years of dormancy, the FDA laboratory developed test (LDT) enforcement volcano stirred on…
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FDA Watch: Agency Finalizes New Medical Device Marketing Pathway & Okays Direct Lab Reporting of PGx Test Results
From - Laboratory Industry Report
On Jan. 22, the FDA issued final guidance establishing a new alternative pathway for getting medical devices to…