New FDA Guidance on General Clinical Trial Conduct in the Era of COVID-19 J. Rick Turner Editor Emeritus Editorial 09 May 2020 Pages: 723 - 724
A Quantitative Study of US FDA Inspection Data for Drug Manufacturing Sites Ajay Babu PazhayattilMarzena IngramNaheed Sayeed Review Article 04 December 2019 Pages: 725 - 730
Adverse Drug Reaction Relief System in Japan: From Clinical Perspective Meguru WatanabeHiroki NishikawaTatsuya Kondo Review Article 05 December 2019 Pages: 731 - 737
Understanding the Essentialities in Establishing the Bioequivalence of Oral Inhalation Drug Products to be Marketed in the USA Swapnil Dylan FernandesMarina Koland Review Article 06 December 2019 Pages: 738 - 748
A Statistical Roadmap for Journey from Real-World Data to Real-World Evidence Yixin FangHongwei WangWeili He Statistics 06 December 2019 Pages: 749 - 757
FDA’s Generic Drug Program: Decreasing Time to Approval and Number of Review Cycles Howard ChazinJason WooJingyu Luan Analytical Report 06 December 2019 Pages: 758 - 763
Use of “Big Data” to Evaluate Responses to Changes in Regulatory Guidelines: Trends in Genotoxicity Testing Packages for New Pharmaceutical Products Lesley ReevePaul BaldrickScott Templeton Research Article 06 December 2019 Pages: 764 - 769
The New Drug Lag: EU Lags in Review Times of Monoclonal Antibodies Vibha SharmaVivek Dasharath DeoreIrwin G. Martin Research Article 06 December 2019 Pages: 770 - 774
Learnings from Patient-Report Workshop on Disease Progression in Myotonic Dystrophy Molly White Meeting Report Open access 09 December 2019 Pages: 775 - 778
Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative Maria ApostolarosDavid BabaianPenny Randall Research Article Open access 09 December 2019 Pages: 779 - 787
Leveraging Research Failures to Accelerate Drug Discovery and Development Helen Yu Research Article 09 December 2019 Pages: 788 - 792
A Review of the Medical Challenges of Using Direct Oral Anticoagulants in Real-World Practice IlYoung Cho Review Article 09 December 2019 Pages: 793 - 802
Risk-Based Quality and Compliance Management in Clinical Trials with Combination Products in Changing Global Regulatory Environment A. O. KaliaevM. A. Malikova Research Article 09 December 2019 Pages: 803 - 813
Considerations and Regulatory Challenges for Innovative Medicines in Expedited Approval Programs: Breakthrough Therapy and Sakigake Designation Eiji KajiwaraMayumi Shikano Research Article 09 December 2019 Pages: 814 - 820
A Framework for Safety Evaluation Throughout the Product Development Life-Cycle Greg BallTjark ReblinFrank W. Rockhold Review Article 09 December 2019 Pages: 821 - 830
From Print to Screen: Regulatory Considerations to Adopting Innovative Approaches for Patient Information and Safety Winona Rei R. BolislisCharlie MortazaviThomas C. Kühler Commentary Open access 09 December 2019 Pages: 831 - 838
Impact of Design on Medical Device Safety Teodora MiclăuşVasiliki VallaEfstathios Vassiliadis Review Article Open access 09 December 2019 Pages: 839 - 849
Reducing Patient Burden in Clinical Trials Through the Use of Historical Controls: Appropriate Selection of Historical Data to Minimize Risk of Bias Jessica LimLi WangKert Viele Analytical Report 10 December 2019 Pages: 850 - 860
An Empirical Investigation of Bayesian Clinical Trial Design in Metastatic Breast Cancer Erik BloomquistSusan JinRajeshwari Sridhara Research Article 10 December 2019 Pages: 861 - 869
Use of Big Data to Aid Patient Recruitment for Clinical Trials Involving Biosimilars and Rare Diseases Raymond A. HumlJill DawsonJonathan R. Huml Analytical Report 11 December 2019 Pages: 870 - 877
Evaluation of the Performance of the South Africa Regulatory Agency: Recommendations for Improved Patients’ Access to Medicines Andrea KeyterSam SalekStuart Walker Research Article Open access 12 December 2019 Pages: 878 - 887
Utilizing Advanced Technologies to Augment Pharmacovigilance Systems: Challenges and Opportunities David John LewisJohn Fraser McCallum Review Article Open access 28 December 2019 Pages: 888 - 899
Toolkit for ICH E6 (R2) Quality Risk Management for Small to Medium Size Companies Andrew Della-ColettaTerry KatzSarah Ann Silvers Research Article 02 January 2020 Pages: 900 - 921
Committing to the Inclusion of Diverse Populations in Clinical Research Hayat R. AhmedDavid H. StraussBarbara E. Bierer Letter 02 January 2020 Pages: 922 - 924
Analysis of FDA Warning Letters Issued to Indian Pharmaceutical and Medical Device Companies: A Retrospective Study Shray BablaniManthan D. Janodia Original Research 06 January 2020 Pages: 925 - 931
When Context Is Hard to Come By: External Comparators and How to Use Them Christina MackJennifer ChristianNancy Dreyer Commentary 06 January 2020 Pages: 932 - 938
Principles and Considerations for Responsible Sharing of Safety Information Via the Medical Information Channel Sashka HristoskovaJames MilliganMILE (Medical Information Leaders Europe) Analytical Report Open access 06 January 2020 Pages: 939 - 946
Graduate Training Capacity for Regulatory Professionals at US Universities: Are We Facing a Talent Crisis? Frances J. RichmondTerry D. Church Original Research 10 January 2020 Pages: 947 - 952
A Comprehensive Analysis of Postmarket Surveillance Study Orders: Device Characteristics, Study Statuses, Outcomes, and Potential Contributions Chie IwaishiKiyotaka Iwasaki Original Research 29 January 2020 Pages: 953 - 963
