A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union: An Analysis of Procedural Timelines Marjolein GarsenMaaike SteenhofAlex Zwiers Original Research Open access 04 February 2021 Pages: 633 - 642
Time to Revisit a Voluntary FDA Comparative Effectiveness Pathway Brian J. MillerVrushab GowdaJodi B. Segal Commentary 10 February 2021 Pages: 643 - 645
Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder Survey Samantha Cruz RiveraBarbara TorlinskaMelanie J. Calvert Original Research Open access 16 February 2021 Pages: 646 - 655
Quality and Authenticity of Metformin Tablets Circulating on Japanese Websites Shu ZhuNaoko YoshidaKazuko Kimura Original Research Open access 17 February 2021 Pages: 656 - 666
Predictability of Severe Adverse Events in Phase 3 Trials from Safety Information on Phase 1 Trials in Oncology Drug Development Takashi SawadaMasayuki KanekoMamoru Narukawa Original Research 02 March 2021 Pages: 667 - 675
A Survey of Survival Outcomes for Targeted Cancer Drugs Approved by the US Food and Drug Administration Qian HeQiu LiLiming Shao Original Research 08 March 2021 Pages: 676 - 684
Factors Influencing Regulatory Decision-Making in Signal Management: Analysis Based on the Signals Identified from the FAERS Chisato FukazawaYasushi HinomuraMamoru Narukawa Original Research 15 March 2021 Pages: 685 - 695
Key Steps Toward a Promotional Communications Strategy: Collaboration Best Practices for Teams Creating Promotional Materials and Regulatory Colleagues Mary L. Raber-JohnsonMark StinsonGeorge J. Wan Review 15 March 2021 Pages: 696 - 704
Interdisciplinary Safety Evaluation for Learning and Decision-Making Greg BallBarbara A. HendricksonJames Buchanan Review 17 March 2021 Pages: 705 - 716
Aggregate Safety Assessment Planning for the Drug Development Life-Cycle Barbara A. HendricksonWilliam WangLothar Tremmel Analytical Report 23 March 2021 Pages: 717 - 732
Protocol Deviations: A Holistic Approach from Defining to Reporting Laura GaluchieCatherine StewartFrank Meloni Analytical Report Open access 29 March 2021 Pages: 733 - 742
US FDA Drug Approvals are Persistent and Polycyclic: Insights into Economic Cycles, Innovation Dynamics, and National Policy Iraj Daizadeh Original Research 30 March 2021 Pages: 743 - 754
Randomized Single-Case Intervention Designs and Analyses for Health Sciences Researchers: A Versatile Clinical Trials Companion Joel R. LevinThomas R. Kratochwill Analytical Report 01 April 2021 Pages: 755 - 764
Design and Analysis of a Biosimilar Bridging Study with a Prediction Interval-Based Consistency Test Zhiying PanWenying HuangGary Koch Original Research 01 April 2021 Pages: 765 - 772
Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children’s Pediatric Innovation Research Forum Gary J. NoelRobert M. NelsonEdward Connor Analytical Report 02 April 2021 Pages: 773 - 778
Sample Size Calculation When Planning Clinical Trials with Intercurrent Events Yixin FangMan Jin Original Research 05 April 2021 Pages: 779 - 785
Measuring Progress of Regulatory Convergence and Cooperation Among Asia–Pacific Economic Cooperation (APEC) Member Economies in the Context of the COVID-19 Pandemic Sannie Siaw Foong ChongMirinea KimJohn C. W. Lim Original Research Open access 11 April 2021 Pages: 786 - 798
Wearable Technologies for Children with Chronic Illnesses: An Exploratory Approach Flora McErlaneElin Haf DaviesAimee Donald Original Research 12 April 2021 Pages: 799 - 806
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 Nobuo UemuraHiroshi KasanukiMitsuo Umezu Original Research Open access 12 April 2021 Pages: 807 - 817
Utility-Based Dose Selection for Phase II Dose-Finding Studies Jihane AouniJean Noel BacroLoic Darchy Original Research 13 April 2021 Pages: 818 - 840
Evaluation of Data Errors and Monitoring Activities in a Trial in Japan Using a Risk-Based Approach Including Central Monitoring and Site Risk Assessment Hidenobu KondoTomoaki KamiyoshiharaTakuhiro Yamaguchi Original Research Open access 19 April 2021 Pages: 841 - 849
Value of Data Sharing to Advance Drug Development: A Regulatory Perspective Aliza ThompsonAmeeta Parekh Commentary 19 April 2021 Pages: 850 - 852
Integrated Analytical Framework for the Development of Artificial Intelligence-Based Medical Devices Hirokazu ArimaShingo Kano Original Research 19 April 2021 Pages: 853 - 865
Vaccines After an Emergency Use Authorization (EUA): Modern Evidence Generation Approaches Névine ZariffaEstelle Russek-Cohen Commentary Open access 22 April 2021 Pages: 866 - 871
The Implementation of the 2020 Roadmap to Promote Good Registration Management (GRM) in APEC Region Hsien-Yi LinYu-Hua HuangChien-Liang Lin Original Research 26 April 2021 Pages: 872 - 880
Analysis of the Real-Time Oncology Review (RTOR) Pilot Program for Approvals of New Molecular Entities Catherine FengRiddhi VirpariaEric T.-K. Mui Review 28 April 2021 Pages: 881 - 888
The Alignment of Real-World Evidence and Digital Health: Realising the Opportunity Sajan KhoslaMaurille Feudjo TepieJohan Liwing Commentary Open access 29 April 2021 Pages: 889 - 898
Risk-Based Monitoring in Clinical Trials: Past, Present, and Future Brian BarnesNicole StansburyPaula Jo Butler Analytical Report Open access 29 April 2021 Pages: 899 - 906
