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
LDTs: FDA Gets Tough with Non-Approved PGx Testing Claims
From - National Intelligence Report
The FDA has apparently set its enforcement sights on Laboratory Developed Tests (LDTs) that claim to predict…
Inside Washington: What’s Going on with Regulation of LDTs?
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New FDA Guidance Tells IVD Makers How to Test for Biotin Interference
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FDA Watch: Agency Okays Marketing of Zika Test for First Time
From - National Intelligence Report
Over the past several years, the FDA has issued Emergency Use Authorization (EUA) for over a dozen different…
Case of the Month: FDA Issues Warning Letter for Unapproved Changes to Approved Assay
From - National Intelligence Report
As a rule of thumb, FDA approvals are a snapshot applicable only to the product as it exists at the time of review and approval…
Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory
Gottlieb Resigns as FDA Chief: Lab Industry Loses a Good Frenemy
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FDA Watch: Latest Plan to Simplify 510(k) Premarket Review of New Tests
From - National Intelligence Report
While everybody agrees that the FDA 510(k) premarket review pathway is antiquated and in desperate need of an overhaul…
Genetic Testing: 23andMe Gets FDA Clearance for Direct-to-Consumer Marketing of Personal Genome Service
From - National Intelligence Report
The FDA is allowing direct-to-consumer marketing, with special controls, of the 23andMe Personal Genome Service Pharmacogenetic Reports test for genetic variants to detect…
LDTs: FDA Announces New Approach to 510(k) Approvals
From - National Intelligence Report
Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including…