Premier Perspectives The blog for insider insights in clinical development Medical and Regulatory Affairs ANDA or 505(b)(2): Choosing the Right Abbreviated Approval Pathway for Your Drug By Kristi Miller June 29, 2021 Featured Posts Study Design Compensating for the Unknown: 3 Keys to Implementing a Successful Decentralized Clinical Trial By Kristi Miller May 13, 2021 Study Design Establishing Competitive Advantage in Dermatology Trials: Critical Study Design and Operational Considerations for a New Age By Kristi Miller January 29, 2021 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 Clinical ResearchPhase 1 - Phase 4 Understanding Recent Regulatory Changes for Pediatric Oncology Trials By Kristi Miller November 13, 2019 × ALSO OF INTERESTGene Therapy 101: From the 1960s to TodayKey Considerations When Designing a Phase 1...7 Questions About Clinical Evaluations for MDR
