FDA publishes LDT rule ‘CliffsNotes’ in guidance for small companies
Regulatory NewsFerdous Al-Faruque
Diagnostics/IVDsGuidanceLaboratory developed tests (LDTs)Regulatory Intelligence/PolicyUnited StatesUS Food and Drug Administration (FDA)Regulatory NewsFerdous Al-FaruqueDiagnostics/IVDsGuidanceLaboratory developed tests (LDTs)Regulatory Intelligence/PolicyUnited StatesUS Food and Drug Administration (FDA)