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Generics Bulletin

Medtech Insight

COVID-19: FDA Eases Approval Policy By Allowing LDT Use Under ‘Immediately In Effect’ Guidance

Mar 01 2020

• By Sue Darcey

Nurse wearing respirator mask holding a positive blood test result for the new rapidly spreading Coronavirus, originating in Wuhan, China

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Additional Topics

United States FDA Guidance Documents Safety Policy Review Pathway Emerging Markets Legislation Quality Coronavirus COVID-19 Infectious Diseases Diagnostics In Vitro Diagnostics Medical Device

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