LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA-lca
Subscribe today for access to
Articles and Reports
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
MeMed Sepsis Test Gains Breakthrough Device Designation
The 15-minute assay to detect sepsis and assess its severity and risk is expected to get full FDA approval by 2026
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…
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