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
FDA-nir
Subscribe today for access to
Articles and Reports
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: Extra Time for Comments on CLIA IVD Waiver Proposals
...
Already a member? Log in here
FDA Watch: Labs Warned that Biotin Interferes with Test Accuracy
...
Already a member? Log in here
LDTs: Top 10 New FDA Diagnostic Approvals of 2017
...
Already a member? Log in here
FDA Watch: Agency to Allow DTC Marketing of Genetic Tests without Premarket Approval
From - National Intelligence Report
The FDA's longstanding policy of restricting direct-to-consumer (DTC) marketing of products without formal premarket approval is well known. But while it always applied to…
FDA Watch: Agency Moves to Boost CLIA Waiver Transparency
From - National Intelligence Report
The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it…
Kellison Award goes to FDA’s Dr. Alberto Gutierrez
From - Laboratory Industry Report
Dr. Alberto Gutierrez is the 2017 recipient of the Kellison Lab Industry Distinguished Service Award. Dr. Guitierrez retired in August after…
Cutting Edge Dx Approvals Threaten FDA’s Fuddy-Duddy Reputation
From - National Intelligence Report
A trio of recent FDA product approvals in the diagnostics space have belied the agency's traditional reputation for resisting medical innovation. Here's the timeline for…
FDA Approves First NGS Oncology Companion Dx for Multiple Therapies
...
Already a member? Log in here
FDA Speeding Approval Process, Continued User Fees Needed
From - National Intelligence Report
The U.S. Food and Drug Administration (FDA) has been chronically plagued with understaffing, an ever expanding workload and…