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 Clinical ResearchPhase 1 - Phase 4 Understanding Recent Regulatory Changes for Pediatric Oncology Trials By Kristi Miller November 13, 2019 1 × ALSO OF INTERESTGene Therapy 101: From the 1960s to TodayKey Considerations When Designing a Phase 1...7 Questions About Clinical Evaluations for MDR