Therapeutic Innovation & Regulatory Science

Article	Citations
The Use of External Controls in FDA Regulatory Decision Making	70
Quality of FDM 3D Printed Medicines for Pediatrics: Considerations for Formulation Development, Filament Extrusion, Printing Process and Printer Design	44
Real World Evidence in Medical Cannabis Research	43
Practical Considerations and Recommendations for Master Protocol Framework: Basket, Umbrella and Platform Trials	33
Implementation of Quality by Design (QbD) Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 2019	25
Laboratory-Developed Tests: Design of a Regulatory Strategy in Compliance with the International State-of-the-Art and the Regulation (EU) 2017/746 (EU IVDR [In Vitro Diagnostic Medical Device Regulati	24
Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action	24
Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies	23
Assessing the Financial Value of Decentralized Clinical Trials	23
Measuring What Matters for Children: A Systematic Review of Frequently Used Pediatric Generic PRO Instruments	18
Risk-Based Monitoring in Clinical Trials: Past, Present, and Future	18
Radiologists and Clinical Trials: Part 1 The Truth About Reader Disagreements	18
Factors Affecting Success of New Drug Clinical Trials	18
Effective Data Sharing as a Conduit for Advancing Medical Product Development	17
Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases	17
Magistral Compounding with 3D Printing: A Promising Way to Achieve Personalized Medicine	16
Developing a More Tailored Approach to Patient and Public Involvement with Children and Families in Pediatric Clinical Research: Lessons Learned	16
Analysis of FDA's Accelerated Approval Program Performance December 1992–December 2021	16
Valuation and Returns of Drug Development Companies: Lessons for Bioentrepreneurs and Investors	16
Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children’s Pediatric Innovation Research Forum	15
Building from Patient Experiences to Deliver Patient-Focused Healthcare Systems in Collaboration with Patients: A Call to Action	15
Patient Engagement Initiatives in Clinical Trials: Recent Trends and Implications	14
Evaluation of the Regulatory Review Process in Zimbabwe: Challenges and Opportunities	14
A Systematic Review of Pharmacovigilance Systems in Developing Countries Using the WHO Pharmacovigilance Indicators	14
Real-World Data as External Controls: Practical Experience from Notable Marketing Applications of New Therapies	13

Application of Meta-analysis to Evaluate Relationships Among ARIA-E Rate, Amyloid Reduction Rate, and Clinical Cognitive Response in Amyloid Therapeutic Clinical Trials for Early Alzheimer’s Disease	12
Extrapolation as a Default Strategy in Pediatric Drug Development	12
Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative	12
Risk-Based Monitoring in Clinical Trials: Increased Adoption Throughout 2020	11
Innovation Pathways in the NHS: An Introductory Review	11
Considerations for Embedding Inclusive Research Principles in the Design and Execution of Clinical Trials	11
Risk-Based Monitoring in Clinical Trials: 2021 Update	11
A Tutorial on Modern Bayesian Methods in Clinical Trials	11
Implementation of ICH E9 (R1): A Few Points Learned During the COVID-19 Pandemic	11
Design and Analysis of Studies Based on Hierarchical Composite Endpoints: Insights from the DARE-19 Trial	11
Aggregate Safety Assessment Planning for the Drug Development Life-Cycle	11
Pediatric Clinical Research Networks: Role in Accelerating Development of Therapeutics in Children	10
Randomized Single-Case Intervention Designs and Analyses for Health Sciences Researchers: A Versatile Clinical Trials Companion	10
Potential Future Drug Development Lag in Japan Based on an Analysis of Multiregional Clinical Trials in the US, Europe, and East Asia	9
Innovations in Therapy Development for Rare Diseases Through the Rare Disease Cures Accelerator-Data and Analytics Platform	9
The Role of Master Protocols in Pediatric Drug Development	9
Bayesian Methods in Human Drug and Biological Products Development in CDER and CBER	9
Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation	9
A Framework for Extension Studies Using Real-World Data to Examine Long-Term Safety and Effectiveness	9
Global Investigative Site Personnel Diversity and Its Relationship with Study Participant Diversity	9
Why are not There More Bayesian Clinical Trials? Perceived Barriers and Educational Preferences Among Medical Researchers Involved in Drug Development	9
The Alignment of Real-World Evidence and Digital Health: Realising the Opportunity	9
Addressing Bias in Responder Analysis of Patient-Reported Outcomes	8
Trends and Characteristics of New Drug Approvals in China, 2011–2021	8
A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China	8
Historical Benchmarks for Quality Tolerance Limits Parameters in Clinical Trials	8
Improving Development of Drug Treatments for Pregnant Women and the Fetus	8
A Composite Endpoint for Acceptability Evaluation of Oral Drug Formulations in the Pediatric Population	8
Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training	7
Navigating Medical Device Certification: A Qualitative Exploration of Barriers and Enablers Amongst Innovators, Notified Bodies and Other Stakeholders	7
Measuring Progress of Regulatory Convergence and Cooperation Among Asia–Pacific Economic Cooperation (APEC) Member Economies in the Context of the COVID-19 Pandemic	7
Wearable Technologies for Children with Chronic Illnesses: An Exploratory Approach	7
Anti-lung Cancer Marine Compounds: A Review	7
Health Equity in Pediatric Drug Development: Translating Aspiration into Operation	7
Regulatory Flexibilities and Guidances for Addressing the Challenges of COVID-19 in the EU: What Can We Learn from Company Experiences?	7
Marking 2-Years of New Thinking in Clinical Trials: The Estimand Journey	7
Protocol Design and Performance Benchmarks by Phase and by Oncology and Rare Disease Subgroups	7
Application of 3D Whole-Brain Texture Analysis and the Feature Selection Method Based on within-Class Scatter in the Classification and Diagnosis of Alzheimer’s Disease	7
Implementation of a Pregnancy Prevention Programme (PPP) with a Controlled Distribution System (CDS) for the Generic Teratogenic Phthalimides Thalidomide, Lenalidomide and Pomalidomide	7
New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19	7
A Comprehensive Nomogram Combining CT Imaging with Clinical Features for Prediction of Lymph Node Metastasis in Stage I–IIIB Non-small Cell Lung Cancer	7
Promoting Best Practices for Medical Science Liaisons Position Statement from the APPA, IFAPP, MAPS and MSLS	7
Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims	6
AI/ML in Precision Medicine: A Look Beyond the Hype	6
A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union: An Analysis of Procedural Timelines	6
Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency	6
Optimising Multi-stakeholder Practices in Patient Engagement: A Gap Analysis to Enable Focused Evolution of Patient Engagement in the Development and Lifecycle Management of Medicines	6
Best Practice Recommendations: User Acceptance Testing for Systems Designed to Collect Clinical Outcome Assessment Data Electronically	6
Radiologists and Clinical Trials: Part 2: Practical Statistical Methods for Understanding and Monitoring Independent Reader Performance	6
Quality Tolerance Limits’ Place in the Quality Management System and Link to the Statistical Trial Design: Case Studies and Recommendations from Early Adopters	6

Regulatory Pathways Supporting Expedited Drug Development and Approval in ICH Member Countries	6
MedDRA Labeling Groupings to Improve Safety Communication in Product Labels	6
Detection of Fraud in a Clinical Trial Using Unsupervised Statistical Monitoring	6
The Competency of Clinical Research Coordinators: The Importance of Education and Experience	6
Open Science to Address COVID-19: Sharing Data to Make Our Research Investment Go Further	6
A Survey of Survival Outcomes for Targeted Cancer Drugs Approved by the US Food and Drug Administration	5
Effect of Hepatitis C Drugs on Blood Coagulability in Patients on Warfarin Using the Medical Information Database Network (MID-NET®) in Japan	5
Assessing the Risk of Decrease in Kidney Function in Patients Prescribed Direct-Acting Antivirals for Hepatitis C Utilizing the MID-NET® Medical Information Database Network in Japan	5
Mixed Models for Repeated Measures Should Include Time-by-Covariate Interactions to Assure Power Gains and Robustness Against Dropout Bias Relative to Complete-Case ANCOVA	5
Digital Tools—Regulatory Considerations for Application in Clinical Trials	5
The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study	5
Bayesian Statistics for Medical Devices: Progress Since 2010	5
Letter to the Editor: New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19	5
Incorporating Competencies Related to Project Management into the Joint Taskforce Core Competency Framework for Clinical Research Professionals	5
Statistical Modeling for Quality Risk Assessment of Clinical Trials: Follow-Up at the Era of Remote Auditing	5
Medication Cost-Savings and Utilization of Generic Inhaled Corticosteroid (ICS) and Long-Acting Beta-Agonist (LABA) Drug Products in the USA	5
Analysis of the Real-Time Oncology Review (RTOR) Pilot Program for Approvals of New Molecular Entities	5
Protocol Deviations: A Holistic Approach from Defining to Reporting	5
Enhancing the Measure of Participation Burden in Protocol Design to Incorporate Logistics, Lifestyle, and Demographic Characteristics	5
Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder Survey	5
Path Forward to Optimise Post-approval Change Management and Facilitate Continuous Supply of Medicines and Vaccines of High Quality Worldwide	5
Accelerating the Availability of Medications to Pediatric Patients by Optimizing the Use of Extrapolation of Efficacy	5
Biosimilars in Malaysia: Regulatory Framework, Approved Products, and Adverse Effects	5
U.S. Food and Drug Administration’s Patient-Focused Drug Development Initiative: Experience with Integration of Patient-Experience Data in a New Drug Application for Esketamine Nasal Spray Plus a Newl	5
elaborator: A Novel App for Insights into Laboratory Data of Clinical Trials	4
Characterization of Pediatric Reports in the US Food and Drug Administration Adverse Event Reporting System from 2010–2020: A Cross-Sectional Study	4
US FDA Drug Approvals are Persistent and Polycyclic: Insights into Economic Cycles, Innovation Dynamics, and National Policy	4
Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development Plans	4
Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance	4
A New Paradigm for Safety Data Signal Detection and Evaluation Using Open-Source Software Created by an Interdisciplinary Working Group	4
Twenty-First Century Global ADR Management: A Need for Clarification, Redesign, and Coordinated Action	4
Opportunities and Risks of UK Medical Device Reform	4
Allopurinol-Induced Severe Cutaneous Adverse Drug Reactions: An Analysis of Spontaneous Reports in Malaysia (2000–2018)	4
Efficacy Endpoints in Phase II Clinical Trials for Meningioma: An Analysis of Recent Clinical Trials	4
Quantifying Diversity and Representation in Pivotal Trials Leading to Marketing Authorization in Europe	4
Leveraging Patient Preference Information in Medical Device Clinical Trial Design	4
A Generalization of the Two Trials Paradigm	4
Risks of Myocarditis and Pericarditis Following Vaccination with SARS-CoV-2 mRNA Vaccines in Japan: An Analysis of Spontaneous Reports of Suspected Adverse Events	4
A Structured Benefit-Risk Assessment Operating Model for Investigational Medicinal Products in the Pharmaceutical Industry	4
The Relative Contributions of NIH and Private Sector Funding to the Approval of New Biopharmaceuticals	4
Use of Real-World Evidence for Drug Regulatory Decisions in China: Current Status and Future Directions	4
Bayesian Strategies in Rare Diseases	4
Unmet Therapeutic Needs of Non-Ambulatory Patients with Duchenne Muscular Dystrophy: A Mixed-Method Analysis	4
Why are There not More Bayesian Clinical Trials? Ability to Interpret Bayesian and Conventional Statistics Among Medical Researchers	4
Value of Data Sharing to Advance Drug Development: A Regulatory Perspective	4
Classification of Companion Diagnostics: A New Framework for Biomarker-Driven Patient Selection	4
Has the COVID-19 Crisis Affected the Growth of United States Food and Drug Administration Drug Approvals? The Answer is Not Yet! A Time Series (Forecasting) Study	4
Study on Horizon Scanning with a Focus on the Development of AI-Based Medical Products: Citation Network Analysis	4
Study on Horizon Scanning by Citation Network Analysis and Text Mining: A Focus on Drug Development Related to T Cell Immune Response	4
Factors that Lead to Stagnation in Direct Patient Reporting of Adverse Drug Reactions: An Opinion Survey of the General Public and Physicians in Japan	4
Interdisciplinary Safety Evaluation for Learning and Decision-Making	3
Heart Failure Population with Therapeutic Response to Sacubitril/Valsartan, Spironolactone and Candesartan: FDA Perspective	3
Validation of CORE-MD PMS Support Tool: A Novel Strategy for Aggregating Information from Notices of Failures to Support Medical Devices’ Post-Market Surveillance	3
Digital Health Technologies in Pediatric Trials	3
The Occurrence of Encephalitis Due to Immune Checkpoint Inhibitors: A Pharmacovigilance Study	3
Sample Size Calculation When Planning Clinical Trials with Intercurrent Events	3
Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: A Global Landscape Review	3
Patient Preferences Regarding Surgical Treatment Methods for Symptomatic Uterine Fibroids	3
Age Demographics of Subjects Enrolled in Global, Interventional Phase 3 Melanoma Clinical Trials	3
Solution Oligonucleotide APIs: Regulatory Considerations	3
EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age	3
Clinical Quality Considerations when Using Next-Generation Sequencing (NGS) in Clinical Drug Development	3
Materiovigilance in Perspective: Understanding Its Concept and Practice in the Global Healthcare System	3
An Overview of Current Statistical Methods for Implementing Quality Tolerance Limits	3
Maximizing Regulatory Review Efficiency: The Evolution of the FDA OCE RTOR Pilot	3
Benchmarking Protocol Deviations and Their Variation by Major Disease Categories	3
Evaluation of Data Errors and Monitoring Activities in a Trial in Japan Using a Risk-Based Approach Including Central Monitoring and Site Risk Assessment	3
Treatment of Death Events in the Analysis of Time to Progression	3
Proof of Concept: Drug Selection? Or Dose Selection? Thoughts on Multiplicity Issues	3
The Evolving Regulatory Paradigm of AI in MedTech: A Review of Perspectives and Where We Are Today	3
Quality and Authenticity of Metformin Tablets Circulating on Japanese Websites	3
Risk Prediction of Central Nervous System Infection Secondary to Intraventricular Drainage in Patients with Intracerebral Hemorrhage: Development and Evaluation of a New Predictive Model Nomogram	3
Impact of Using A Mixed Data Collection Modality on Statistical Inferences in Decentralized Clinical Trials	3
Factors Influencing Classifications of Safety Specifications in a Risk Management Plan for Antineoplastic Agents Approved in Japan: A Review and Descriptive Analysis	3
Safety and Effectiveness of Multiple Switching Between Originators and Biosimilars: Literature Review and Status Report on Interchangeability	3
Applying Systems Thinking to Inform Decentralized Clinical Trial Planning and Deployment	3
Common Deficiencies Found in the Active Pharmaceutical Ingredient (API) Section of Non-sterile Generic Products Submitted for Registration by SAHPRA	3
Changes in Companion Diagnostic Labelling: Implementation of FDA’s April 2020 Guidance for Industry for In Vitro CDx Labeling for Specific Oncology Therapeutic Groups	3
Evaluating the Feasibility and Validity of a New Tool to Assess Organizational Preparedness and Capabilities to Support Patient Engagement in Drug Development	3
Awareness of Clinical Research Coordinators Toward Ethics and Protection of Clinical Trial Patients	3

Accelerating Pediatric Drug Development: A 2022 Special Issue of Therapeutic Innovation & Regulatory Science	3
Pharmacometrics: The Already-Present Future of Precision Pharmacology	3
Data-Driven Subgroup Identification in Confirmatory Clinical Trials	3
An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling	3
Exploring How and Why to Develop Patient-Centered Packaging: A Multiple-Case Study with Pharmaceutical Companies	3
Direct-to-Consumer Genetic Testing: A Comprehensive Review	3
Efficient Risk Mitigation Planning for a Clinical Trial	2
The Role of Regulatory Sciences from the Perspective of the Cuban Medicines Regulatory Agency: The Impact of COVID-19 in Promoting Innovation, Cooperation and Scientific Thinking	2
New Visualization Models of Designation Pathway and Group Categorization of Device–Drug and Device–Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions	2
A Proposal for Post Hoc Subgroup Analysis in Support of Regulatory Submission	2
Digital Health Technologies in Clinical Trials: An Ontology-Driven Analysis to Inform Digital Sustainability Policies	2
Integrating Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices	2
Factors Influencing Regulatory Decision-Making in Signal Management: Analysis Based on the Signals Identified from the FAERS	2
RETRACTED ARTICLE: Seasonal and Secular Periodicities Identified in the Dynamics of US FDA Medical Devices (1976–2020): Portends Intrinsic Industrial Transformation and Independence of Certain Crises	2
Approaches to Design an Efficient, Predictable Global Post-approval Change Management System that Facilitates Continual Improvement and Drug Product Availability	2
The Medical Science Liaison Role in Spain: A Survey About the Opinion of HealthCare Professionals	2
Challenges in Implementing Futility Schemes, with Reference to Aducanumab	2
Co-Development of Oncology Drugs and Companion Diagnostics: Analyses of Approval Lags and Drug Development Periods in Recently Approved Cases in Japan	2
Medical Information Practices Across the Pharma Industry: What Can We Learn from Benchmarking Surveys?	2
Training New DMC Members: A Call to Action	2
Asia Partnership Conference of Pharmaceutical Associations (APAC) Report on Regulatory Agility Implemented During the COVID-19 Pandemic: Inspiring Partnerships and Recommendations for the Way Forward	2
Review of the Food and Drug Administration’s Center for Drug Evaluation and Research Program for New Molecular Entities: Trends and Regulatory Requirements in Acknowledgment Letters and Filing Communi	2
New Drug and Biologics Approvals in 2019: A Systematic Analysis of Patient Experience Data in FDA Drug Approval Packages and Product Labels	2
Does Central Monitoring Lead to Higher Quality? An Analysis of Key Risk Indicator Outcomes	2
Demonstrating that Real World Evidence Is Fit-For-Purpose to Support Labeling: Parallels to Patient Reported Outcomes in the Pursuit of Labeling Claims	2
Government Pharmaceutical Development to Address High Prices: Challenges Ahead	2
Ivermectin in COVID-19: The Case for a Moratorium on Prescriptions	2
Evolution of Phase II Oncology Trial Design: from Single Arm to Master Protocol	2
Integrated Analytical Framework for the Development of Artificial Intelligence-Based Medical Devices	2
Optimal Sample Size for Use in Neonatal Pharmacokinetic Studies	2
Aiding the Adoption of Master Protocols by Optimizing Patient Engagement	2
Planning Benefit-Risk Assessments Using Visualizations	2
Risk Management in Drug-Device Combination Product Development	2
Integrative Analysis of Randomized Clinical Trial and Observational Study Data to Inform Post-marketing Safety Decision-Making	2
Insights from a Multi-company Workshop to Apply a Patient Participation Burden Algorithm to Protocol Data	2
Pathway for Development and Validation of Multi-domain Endpoints for Amyloid Light Chain (AL) Amyloidosis	2
Evaluation of a Pilot: Inspection Facilitation and Collaboration Using a Mixed Reality Device	2
From Meaningful Outcomes to Meaningful Change Thresholds: A Path to Progress for Establishing Digital Endpoints	2
Medicinal Product Development and Regulatory Agilities Implemented During the Early Phases of the COVID-19 Pandemic: Experiences and Implications for the Future—An Industry View	2
Comparison of the Latin America Regulation Landscape and International Reference Health Authorities to Hasten Drug Registration and Clinical Research Applications	2
Principles for Good Practice in the Conduct of Non-interventional Studies: The View of Industry Researchers	2
Randomized Controlled Trial Data for New Drug Application for Rare Diseases in Japan	2
Expedited Development Programs at the Food and Drug Administration: Insights and Opportunities	2
Comparison of Regulations for Arsenic and Heavy Metals in Herbal Medicines Using Pharmacopoeias of Nine Counties/Regions	2
The Integrated Review: FDA Modernizes the Review of New Drug Marketing Applications	2
Changes in the Review Period of Drug Application and a Drug Lag from the FDA and the EMA: An Industry Survey in South Korea Between 2011 and 2020	2
Statistical Considerations on the Use of RWD/RWE for Oncology Drug Approvals: Overview and Lessons Learned	2
Zero-Inflated Binomial Model for Meta-Analysis and Safety-Signal Detection	2
Quality Tolerance Limits: A General Guidance for Parameter Selection and Threshold Setting	2
Estimation of the Under-Reporting of Suspected Serious Adverse Drug Reactions in Japan Using An Interrupted Time Series Analysis	2
Exploratory Analysis of Drug Lag in New Oncology Drugs Between Japan and the US	2
Human Medicines Recall Announcements in Saudi Arabia Between 2017 and 2022: An Analysis of Saudi Food and Drug Authority (SFDA) Reports	2
Efficacy Comparison for a Schizophrenia and a Dysuria Drug Among East Asian Populations: A Retrospective Analysis Using Multi-regional Clinical Trial Data	2
Preventability of Adverse Drug Reactions Related to Antibiotics: An Assessment Based on Spontaneous Reporting System	1
Comparing Go/No-Go Decision-Making Properties Between Single Arm Phase II Trial Designs in Oncology	1
Using Bayesian Dynamic Borrowing to Maximize the Use of Existing Data: A Case-Study	1
Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations	1
Benchmarking Patient Engagement Capabilities and Preparedness of Drug Development Sponsors	1
Adverse Events in the Digital Age: Finding the Sharpest Tool in the Box	1
How Many Clinical Trials Exist that Have Adopted Selective Safety Data Collection? NEJM Literature Search Results: The Possibility of Harmonizing the ICH E19 Guideline	1
Use of Real-World Evidence in Regulatory Decisions for Traditional Chinese Medicine: Current Status and Future Directions	1
The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data	1
Regulation of Drug Prescribing Information in Latin America and the Caribbean	1
Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial	1
Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation	1
Complexity of Data Displays in Prescription Drug Advertisements for Healthcare Providers	1
The Medical Science Liaison Role in Spain: A Survey Capturing the Opinion of Medical Department Professionals	1
Assessment of the Relationship Between Protocol Adherence, Study Complexity and Personnel in Surgical Clinical Trials	1
Nature of the Interaction of Alpha-D-Mannose and Escherichia coli Bacteria, and Implications for its Regulatory Classification. A Delphi Panel European Consensus Based on Chemistry and Legal Evidence	1
First Approval of Generic Mometasone Furoate Nasal Suspension Spray in Japan: Similarities and Differences Between Japan and the USA	1
Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017–2019	1
Key Steps Toward a Promotional Communications Strategy: Collaboration Best Practices for Teams Creating Promotional Materials and Regulatory Colleagues	1
Comprehensive Analysis of Clinical Studies and Regulations of Therapeutic Applications in the United States and Japan	1
Analysis of a Binary Outcome Dichotomized from an Underlying Continuous Variable in Clinical Trials	1
Healthy Volunteer Studies in the Development of Anticancer Drugs with Genotoxic Findings	1
Decentralized Clinical Trials: Scientific Considerations Through the Lens of the Estimand Framework	1
Adaptation of the WOMAC for Use in a Patient Preference Study	1
Aggregate IND Safety Reporting for Smaller Companies and Programs	1
Impact of Tumor Assessment Frequency on Statistical Power in Randomized Cancer Clinical Trials Evaluating Progression-Free Survival	1
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	1
Japanese Regulatory Considerations for Interoperability of Medical Devices	1
Predicting the Addition of Information Regarding Clinically Significant Adverse Drug Reactions to Japanese Drug Package Inserts Using a Machine-Learning Model	1
New Benchmarks on Demographic Disparities in Pivotal Trials Supporting FDA-Approved Drugs and Biologics	1
Regulatory Reform Outcomes and Accelerated Regulatory Pathways for New Prescription Medicines in Australia	1
Validation of Artificial Intelligence Containing Products Across the Regulated Healthcare Industries	1
Utility-Based Dose Selection for Phase II Dose-Finding Studies	1
Comparison of Good Clinical Practice Inspection Processes for Marketing Applications Between the United States Food and Drug Administration and the European Medicines Agency	1
The Implementation of the 2020 Roadmap to Promote Good Registration Management (GRM) in APEC Region	1
Comprehensive Assessment of Risk-Based Quality Management Adoption in Clinical Trials	1
Leveraging Real-World Data in Safety Signal Assessment	1
False Negative ECG Device Results May Increase the Risk of Adverse Events in Clinical Oncology Trials	1
The Data Monitoring Committee: A Collective or a Collection?	1
Characterizing Pain Points in Clinical Data Management and Assessing the Impact of Mid-Study Updates	1
Characteristics of Asian Participation in Multi-regional Clinical Trials Reviewed for Drug Approval in Japan: Opportunities for Collaboration Between South-East Asia, East Asia, and Japan	1
The Predictive Individual Effect for Survival Data	1