New VALID Act Would Establish Risk-Based System for LDTs Regulation
Senate committee members propose a modified version of legislation allowing the FDA to continue to regulate LDTs on a risk-tiered basis.
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HHS Restores Agency’s Premarket Review of LDTs
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Agency Regains Its Authority to Regulate Laboratory Developed Tests (LDTs)
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Agency Regains Its Authority to Regulate Laboratory Developed Tests (LDTs)
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FDA Imposes New Limits on COVID-19 Tests with Access to EUA Pathway
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