New Enhancing CLIA Act: What Lab Directors Need to Know
The proposal seeks to move any future LDT authority away from the FDA
Already a member? Log in here
FDA-lca
Subscribe today for access to
Articles and Reports
FDA Watch: Natera, Valar Labs Receive FDA Clearances for Bladder Cancer Tests
Natera’s assay focuses on the need for adjuvant therapy, while Valar’s test stratifies risk of recurrence
Already a member? Log in here
FDA Watch: MeMed and NG Biotech Receive FDA Breakthrough Device Designations for Rapid Infection Tests
In both cases, the diagnostic tests report results back within 15 minutes
Already a member? Log in here
FDA Warns About Biotin Interference With Lab Tests
...
Already a member? Log in here
CLIA Corner: FDA Moves to Boost CLIA Waiver Transparency
...
Already a member? Log in here
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…
Already a member? Log in here
Liquid Biopsies Get FDA Attention
...
Already a member? Log in here
Congressional Leaders Query FDA and CMS about Theranos
...
Already a member? Log in here
FDA Guidance Addresses NGS Testing, Espousing Flexibility in Oversight
...
Already a member? Log in here