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
Debate Continues Over FDA Regulation of LDTs
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Colon Cancer Screening Test Gets FDA Approval, Proposed Medicare Coverage
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FDA Plans to Regulate Lab-Developed Tests Could Increase Time and Cost of Development
In its July 31 notice to Congress, the agency says it would phase in oversight requirements over nine years.
FDA Official Defends Plan to Issue Guidance for LDTs
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FDA Lowers Risk Classifications For Bone Marrow, Diabetes Diagnostic Tests
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Lab Execs Air Concerns Over FDA Regulation of LDTs
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Labs Urged to Coordinate With CDC on Ebola Testing
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FDA to Hold Workshop on LDTs
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Lab Sector Goes to Big Legal Guns in Grapple With FDA Over Test Regulation
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CMS Releases New CLIA-Waived Tests, Billing Codes
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