Premier Perspectives The blog for insider insights in clinical development Medical and Regulatory Affairs FDA’s LDT Proposal and Its Impact on Clinical and Regulatory Professionals By Charles Chrisawn March 6, 2024 Featured Posts Consulting The Economics of Investigational Device Exemption (IDE) Studies: What You Need to Know About Medicare Coverage By Charles Chrisawn January 29, 2024 Consulting Conducting Clinical Studies Under an Investigational Device Exemption By Charles Chrisawn January 29, 2024 Recent Posts By expertise area All expertise areas Medical DeviceRare DiseaseOncology & HematologyDiagnosticsDigital TherapeuticsMedTechPediatricsNeuroscienceAnalgesiaDermatologyOtherCOVID-19Cell & Gene TherapyWomen's HealthReal-World & Late PhaseCareers By functional area All functional areas Development StrategyClinical Research: Phase 1 - Phase 4ConsultingData Management & BiostatisticsFunctional Service Provider (FSP)Global ComplianceMedical and Regulatory AffairsPatient and Stakeholder EngagementProject ManagementQualityReal-World Science and Late PhaseSafety/PharmacovigilanceStudy DesignStudy Start-UpOtherCOVID-19Product Development Consulting Is Your In Vitro Diagnostic Exempt from Investigational Device Exemption Regulations? By Charles Chrisawn January 17, 2024 Clinical ResearchPhase 1 - Phase 4 A Different Pace: Meeting the Demands of Liquid Biopsy Development for Early Cancer Detection By Charles Chrisawn July 18, 2023 Clinical ResearchPhase 1 - Phase 4 It’s Better for Everyone: The Promise of Liquid Biopsy as a Cancer Screening Tool By Charles Chrisawn July 17, 2023 Clinical ResearchPhase 1 - Phase 4 How to Establish Clinical Utility of Molecular Diagnostics for Precision Medicine: 5 Tips on RCT Conduct By Charles Chrisawn April 19, 2022 Clinical ResearchPhase 1 - Phase 4 How to Establish Clinical Utility of Molecular Diagnostics for Precision Medicine: 5 Tips on RCT Design By Charles Chrisawn April 11, 2022 Clinical ResearchPhase 1 - Phase 4 FAQs: In Vitro Diagnostic Medical Device Regulation By Charles Chrisawn March 14, 2022 × ALSO OF INTERESTGene Therapy 101: From the 1960s to Today7 Questions About Clinical Evaluations for MDRNostalgia or Shell Shock? Assessing PTSD Is a...