Using Bayesian Dynamic Borrowing to Maximize the Use of Existing Data: A Case-Study Dawn EdwardsN. BestA. Fowler Analytical Report Open access 01 November 2023 Pages: 1 - 10
Evaluation of a Pilot: Inspection Facilitation and Collaboration Using a Mixed Reality Device Peter BakerTamika CatheyJared R. Auclair Analytical Report Open access 22 November 2023 Pages: 11 - 15
The Term ‘Deselect’ is Ambiguous as Used in Research Studies to Support Prescription to Nonprescription Switches Eric P. Brass Letter to the Editor 18 October 2023 Pages: 16 - 17
Risk-Based Quality Management: Who Should Be in the Room and When While Assessing Risks During a Clinical Trial? Terry KatzMaryrose PetrizzoMunish Mehra Letter to the Editor 07 November 2023 Pages: 18 - 20
Regulatory Framework, Challenges, and Initial Strategic Planning for Advanced Therapy Products (PTAs) Development in Brazil Flávia Nathiely Silveira FachelRoselena Silvestri SchuhUrsula Matte Review 10 October 2023 Pages: 21 - 33
Use of Real-World Evidence in Regulatory Decisions for Traditional Chinese Medicine: Current Status and Future Directions Pei LiSu WangYuwen Chen Review Open access 23 November 2023 Pages: 34 - 41
Enrollment Forecast for Clinical Trials at the Planning Phase with Study-Level Historical Data Mengjia YuSheng ZhongLi Wang Original Research 15 September 2023 Pages: 42 - 52
Knowledge and Attitudes of Clinical Trials among Patients with Rare Diseases and the Guardians in China Ziling XiangHui JiangHang Zheng Original Research 18 September 2023 Pages: 53 - 62
Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: A Global Landscape Review Neil BertelsenLode DewulfNicholas Brooke Original Research Open access 24 September 2023 Pages: 63 - 78
Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations Marina GhadanianEllen Schafheutle Original Research Open access 20 October 2023 Pages: 79 - 113
Imputation of Missing Data for Time-to-Event Endpoints Using Retrieved Dropouts Shuai WangRobert FrederichJames P. Mancuso Original Research Open access 07 October 2023 Pages: 114 - 126
Non-monotone Exponential Time (NEXT) Model for the Longitudinal Trend of a Continuous Outcome in Clinical Trials Ran DuanKaiyi ChenYongming Qu Original Research 26 September 2023 Pages: 127 - 135
Impact of the US Accelerated Approval for New Anticancer Drugs on Time to Verification of Benefit and Regulatory Approval in the EU and Japan Akira ItoMamoru Narukawa Original Research 03 October 2023 Pages: 136 - 142
New Benchmarks on Demographic Disparities in Pivotal Trials Supporting FDA-Approved Drugs and Biologics Zachary SmithEmily BottoKenneth Getz Original Research 29 September 2023 Pages: 143 - 152
An Evaluation of the Swissmedic Regulatory Framework for New Active Substances Magda BujarSimon Andreas Dalla Torre di SanguinettoNeil McAuslane Original Research Open access 26 October 2023 Pages: 153 - 165
Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study Sampada GandhiBenjamin TaylorKevin Wolter Original Research 27 October 2023 Pages: 166 - 174
Quantifying Clinical Trial Diversity in Pivotal Registration Trials of FDA Novel Drug Approvals Muhammed Y. IdrisWilliam E. FitzsimmonsPriscilla Pemu Original Research 23 October 2023 Pages: 175 - 183
Use of Mean Kinetic Temperature for Pharmaceuticals in Japan and Stability Monitoring in the 21st Century Ensei Miura Original Research 27 October 2023 Pages: 184 - 191
Lower Risks of Gastrointestinal Perforation and Intestinal Obstruction in Patients with Atypical Antipsychotics in Comparison with Typical Antipsychotics Based on Real-World Data from the MID-NET® in Japan Tomoaki HasegawaSono SawadaYoshiaki Uyama Original Research Open access 29 October 2023 Pages: 192 - 199
An Update from the Benchmark Survey of phactMI™ Member Companies on Providing Medical Information in the Digital Space Sheena DupuyLaura OpincarEvelyn R. Hermes-DeSantis Original Research Open access 10 November 2023 Pages: 200 - 213
Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017–2019 Atasi PoddarMiranda RaggioJohn Concato Original Research Open access 05 November 2023 Pages: 214 - 221
