FDA Watch: CDRH Budget May Not See Steep Cuts in FY 2026
A leaked budget document for the next fiscal year suggested non-user fee funding may be up slightly compared to recent years.
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Articles and Reports
Next Steps: With LDT Final Rule Now Null, Industry Groups Urge Lab Managers and Pathologists to Advocate for Change
CAP and AMP officials weigh in on plans to push for a legislative- or CLIA-based approach to future LDT oversight
LDT Appeal: Looking at the Legal Nuances Behind Potential FDA Actions Following Court Decision
Marginal LDT scenarios could be where the FDA focuses on next, a lawyer notes
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…
FDA Watch: Agency Floats Plan to Simplify 510(k) Premarket Review
From - Laboratory Industry 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…
FDA Watch: First NGS Residual Cancer Detection Test Wins Approval
From - Laboratory Industry Report
The FDA broke new ground by allowing marketing of Adaptive Biotechnologies' ClonoSEQ assay, a next generation sequencing (NGS)-based test for…
FDA Watch: Changes to CBER Email Policy May Affect Your Lab
From - Laboratory Industry Report
Heads up to any lab that's subject to oversight by the CBER, i.e., the FDA agency responsible for regulating biological products for human use…
