Premier Perspectives The blog for insider insights in clinical development Clinical Research: Phase 1 - Phase 4 Using the 505(b)(2) Pathway to Streamline Regulatory Approval for Combination Products By Ann Leonard October 26, 2021 Featured Posts Medical and Regulatory Affairs The FDA Is Ending Its Rare Pediatric Disease Priority Review Vouchers – and Time Is Running Out to Get One By Ann Leonard July 31, 2020 Consulting UPDATE – Draft FDA Guidance Concerning Combination Products By Ann Leonard March 18, 2020 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 INTERACT Meetings: Streamlining Early Clinical Development By Ann Leonard February 19, 2020 × ALSO OF INTERESTKey Considerations When Designing a Phase 1...7 Questions About Clinical Evaluations for MDRNostalgia or Shell Shock? Assessing PTSD Is a...
