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 Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Government Shutdown: The Impact on the Agencies that Regulate Labs
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FDA Warns About Biotin Interference With Lab Tests
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CLIA Corner: FDA Moves to Boost CLIA Waiver Transparency
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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
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Congressional Leaders Query FDA and CMS about Theranos
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FDA Guidance Addresses NGS Testing, Espousing Flexibility in Oversight
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