LDTs - G2 Intelligence

Final Rule Clarifies Liability for Off-Label Uses and Lab’s Right to Create LDTs

Final Rule Clarifies Liability for Off-Label Uses and Lab’s Right to Create LDTs

by Glenn S. Demby | Sep 13, 2021 | Articles, Essential, FDA-lir, Laboratory Industry Report, LDTs-lir

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Agency Imposes 2.5 Percent Increase in 2022 Premarket Application User Fees

Agency Imposes 2.5 Percent Increase in 2022 Premarket Application User Fees

by Glenn S. Demby | Sep 6, 2021 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

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New LCD Expanding Medicare Coverage for Circulating Tumor Cells Tests Is a Win for Biocept

New LCD Expanding Medicare Coverage for Circulating Tumor Cells Tests Is a Win for Biocept

by Glenn S. Demby | Aug 23, 2021 | Articles, Clinical Diagnostics Insider, CMS-nir, Diagnostic Testing and Emerging Technologies, Industry Buzz-lir, Laboratory Industry Report, National Lab Reporter

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FDA Watch: VALID and VITAL Bills for LDTs Regulation Are Back in Play

FDA Watch: VALID and VITAL Bills for LDTs Regulation Are Back in Play

by Glenn S. Demby | Aug 17, 2021 | Articles, Essential, FDA-lir, Laboratory Industry Report

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New LCD Expanding Medicare Coverage for Circulating Tumor Cells Tests Is a Win for Biocept

Congress Retables VALID and VITAL Legislation to Regulate LDTs

by Glenn S. Demby | Aug 5, 2021 | Articles, Essential, FDA-lca, Lab Compliance Advisor

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