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
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CLIA: CMS Issues Guidance on How Labs Should Perform Coronavirus Testing
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Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests
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FDA Targets Sale of IVD Reagents without Premarket Approval
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FDA Resounds the Alarm on Biotin Test Interference
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New Product Development: FDA Issues Final Guidance on IVD Oncology Trials
On Oct. 10, 2019, the FDA finalized guidance on an optional streamlined submission process to determine whether
LDTs: FDA Gets Tough with Non-Approved PGx Testing Claims
From - National Intelligence Report
The FDA has apparently set its enforcement sights on Laboratory Developed Tests (LDTs) that claim to predict…
Inside Washington: What’s Going on with Regulation of LDTs?
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New FDA Guidance Tells IVD Makers How to Test for Biotin Interference
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