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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Agency Clears Record Number of New Medical Devices in 2020
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Ortho Clinical Diagnostics Gets Green Light for Mass SARS-CoV-2 Antigen Test
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Agency Greenlights First Over-the-Counter, At-Home COVID-19 Testing Kit
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Lucira Health Secures First EUA for Fully At-Home COVID-19 Testing Kit
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Agency Temporarily Allows Modifications of Influenza and RSV Tests Without Premarket Notification
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