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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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
LDTs: Top 10 New FDA Diagnostic Approvals of 2017
From - Laboratory Industry Report
The phrase "most exciting FDA laboratory developed test approvals of the year" is no longer an oxymoron. The agency remains glacial in tempo…
FDA Watch: New Policy Would Allow DTC Marketing of Genetic Tests without Premarket Approval
From - Laboratory Industry Report
For years, the lab industry has been pressing the FDA to relinquish its rigorous oversight of direct-to-consumer (DTC) genetic health tests…
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…
FDA Watch: New Moves to Boost CLIA Transparency
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FDA Watch: Diagnostics Industry Is Losing a Longstanding “Frenemy”
From - Laboratory Industry Report
The diagnostics community is saying goodbye to a frenemy of 25 years. On Aug. 29, Alberto Gutierrez, director of the…
FDA Watch: Two More Zika Tests Get Emergency Use Authorization
From - Laboratory Industry Report
Zika made the FDA headlines this month, with two more tests receiving emergency use authorization…
FDA Watch: Another First as Agency Approves NGS Oncology Companion Dx for Multiple Therapies
From - Laboratory Industry Report
The FDA made a stir in May by approving a cancer drug (Keytruda (pembrolizumab) PD-1/PD-L1 inhibitor from Merck) administered on the basis of a…
FDA Watch: User Fees Dodge a Bullet, a Cancer Drug Approval Breaks New Ground and the Supreme Court Serves Up a Biosims Blockbuster
From - Laboratory Industry Report
The FDA budget pot continues to boil. In March, the Trump administration proposed a controversial provision to double the medical user fees that diagnostics, medical device and…
FDA Watch: Congress Kills Trump Plan to ‘Recalibrate’ User Fees
From - Laboratory Industry Report
Instead of the budget cuts the President asked for, the newly approved federal government spending plan increases FDA funding by…