Quality Tolerance Limits: Framework for Successful Implementation in Clinical Development Ruma BhagatLukasz BojarskiSabine Turri Analytical Report Open access 03 September 2020 Pages: 251 - 261
A Multifaceted Perspective of Pharmaceutical Innovation: A Consideration of the Regulatory Role Mark RobbersonChristopher D. Breder Original Research 31 August 2020 Pages: 262 - 269
Emergency Use Authorization for Remdesivir and Its Potential Implications Cassius Iyad Ochoa ChaarRobert Makuch Commentary 03 September 2020 Pages: 270 - 271
Evolving Clinical Data Strategies and Tactics in Response to Digital Transformation Beth HarperMichael WilkinsonKen Getz Original Research 14 September 2020 Pages: 272 - 281
Ethical Considerations for Pediatric Placebo-Controlled Trials: FDA Outcomes and Perspectives Jeremiah D. MomperDionna J. GreenDonna L. Snyder Original Research 08 September 2020 Pages: 282 - 303
Legislation on the Roles of the Pharmacist and Pharmacy in the Revision of the Pharmaceutical and Medical Device Act and the Pharmacists Act in Japan Kento TakamuraKeisuke TachibanaMasuo Kondoh Review 11 September 2020 Pages: 304 - 308
Update of EMA’s Guideline on the Environmental Risk Assessment (ERA) of Medicinal Products for Human Use Ralf Arno Wess Review 29 September 2020 Pages: 309 - 323
Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development Brian PerryCarrie DombeckAmy Corneli Original Research Open access 29 September 2020 Pages: 324 - 335
Analysis of Pediatric Drug Approval Lag in Japan Eiji UeyamaMasayuki KanekoMamoru Narukawa Original Research 21 September 2020 Pages: 336 - 345
Graphical Analyses in the Regulatory Evaluation of Gene Therapy Applications Xue LinShiowjen LeeMin Lin Review 21 September 2020 Pages: 346 - 359
Bayesian Design for Pediatric Clinical Trials with Binary Endpoints When Borrowing Historical Information of Treatment Effect Man JinQing LiAmarjot Kaur Original Research 21 September 2020 Pages: 360 - 369
Accelerating Rare Disease Drug Development: Lessons Learned from Muscular Dystrophy Patient Advocacy Groups Raymond A. HumlJill DawsonJonathan R. Huml Analytical Report 24 September 2020 Pages: 370 - 377
Characteristics of Industry-Sponsored Drug Clinical Trials Registered in Japan Pharmaceutical Information Center Clinical Trials Information 2010–2018 Eriko KobayashiMidori MatsuyamaMamoru Narukawa Original Research 06 October 2020 Pages: 378 - 387
Dynamic Dossier in the Cloud: A Sociotechnical Architecture for a Real-Time and Metrics-Based Data Tracking System with Gene and Cell Therapies as a Case Study Kevin NamKay LarholtMatt W. Courtney Original Research Open access 28 October 2020 Pages: 388 - 400
Comparative Assessment of Non-trial Access to Investigational Medical Products in the U.S. and Japan Haruka NakadaKelly McBride FolkersKyoko Takashima Original Research 23 October 2020 Pages: 401 - 407
The Road to Pharmacovigilance Outsourcing Guidance Bert van LeeuwenBrian Edwards Review 28 October 2020 Pages: 408 - 414
Quantitative Benefit–Risk Assessment: State of the Practice Within Industry Meredith Y. SmithJanine van TilKevin Marsh Original Research Open access 27 October 2020 Pages: 415 - 425
Over-the-Counter Drugs: Regulatory Analysis of Warning Letters Between Fiscal Years 2015–2019 Helen K. BaiJennifer D. AhearnMichael G. Bartlett Original Research 23 October 2020 Pages: 426 - 436
Since the Mid-2010s FDA Drug and Biologic Guidelines have been Growing at a Faster Clip than Prior Years: Is it Time to Analyze Their Effectiveness? Iraj Daizadeh Commentary 22 October 2020 Pages: 437 - 439
New Drugs Regulatory Program Modernization: Vision, Strategic Objectives, and Impact Kevin BuginJanet WoodcockYonatan Tyberg Analytical Report 26 October 2020 Pages: 440 - 446
Text Classification for Clinical Trial Operations: Evaluation and Comparison of Natural Language Processing Techniques Emma RichardBhargava Reddy Original Research 30 October 2020 Pages: 447 - 453
Identifying Anticipated Events of Future Clinical Trials by Leveraging Data from the Placebo Arms of Completed Trials Xiang-Lin TanDavid M. KernM. Soledad Cepeda Original Research Open access 09 November 2020 Pages: 454 - 461
Correction to: Patient Contribution to the Development and Safe Use of Medicines During the Covid-19 Pandemic Peter J. PittsFrançois Houÿez Correction 05 November 2020 Pages: 462 - 462
New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19 Max Wegner Commentary 25 November 2020 Pages: 463 - 466
