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 AnalgesiaDermatologyMedical DeviceNeuroscienceOncology & HematologyPediatricsRare DiseaseOtherCOVID-19Cell & Gene TherapyWomen's HealthDiagnosticsReal-World & Late Phase By functional area All functional areas Clinical 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 INTEREST7 Questions About Clinical Evaluations for MDRGene Therapy 101: From the 1960s to TodayDesigning Pediatric Analgesic Treatment...
