Risk Management in Drug-Device Combination Product Development Robin KumoluyiAmit Khanolkar Commentary Open access 26 June 2022 Pages: 685 - 688
Changes in Companion Diagnostic Labelling: Implementation of FDA’s April 2020 Guidance for Industry for In Vitro CDx Labeling for Specific Oncology Therapeutic Groups Lisa CooperJoyce Chen Review Open access 10 June 2022 Pages: 689 - 697
Analysis of FDA's Accelerated Approval Program Performance December 1992–December 2021 Ginny Beakes-ReadMadison NeisserMara Guarducci Review Open access 28 July 2022 Pages: 698 - 703
Real-World Data as External Controls: Practical Experience from Notable Marketing Applications of New Therapies Rima IzemJoan BuenconsejoMargaret Gamalo Review 08 June 2022 Pages: 704 - 716
A Systematic Review of Pharmacovigilance Systems in Developing Countries Using the WHO Pharmacovigilance Indicators Hamza Y. GarashiDouglas T. SteinkeEllen I. Schafheutle Review Open access 03 June 2022 Pages: 717 - 743
Impact of Using A Mixed Data Collection Modality on Statistical Inferences in Decentralized Clinical Trials Alexandra CurtisYongming Qu Original Research 24 May 2022 Pages: 744 - 752
Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency Jenn W. SellersCamelia M. MihaescuNi A. Khin Original Research Open access 24 May 2022 Pages: 753 - 764
Publisher Correction: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency Jenn W. SellersCamelia M. MihaescuNi A. Khin Correction Open access 30 May 2022 Pages: 765 - 766
Correction to: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency Jenn W. SellersCamelia M. MihaescuNi A. Khin Correction Open access 06 June 2022 Pages: 767 - 767
Innovations in Therapy Development for Rare Diseases Through the Rare Disease Cures Accelerator-Data and Analytics Platform Jane LarkindaleAlexandre BetourneJeffrey S. Barrett Original Research 06 June 2022 Pages: 768 - 776
Global Investigative Site Personnel Diversity and Its Relationship with Study Participant Diversity Kenneth GetzMaria FlorezOmer Abdullah Original Research 10 June 2022 Pages: 777 - 784
Design and Analysis of Studies Based on Hierarchical Composite Endpoints: Insights from the DARE-19 Trial Samvel B. GasparyanJoan BuenconsejoMikhail N. Kosiborod Original Research 14 June 2022 Pages: 785 - 794
Quantifying Diversity and Representation in Pivotal Trials Leading to Marketing Authorization in Europe Zachary SmithEmily BottoKenneth Getz Original Research 09 June 2022 Pages: 795 - 804
The Medical Science Liaison Role in Spain: A Survey Capturing the Opinion of Medical Department Professionals Adela Matesanz-MarínAntonio González del CastilloCristina García Original Research 21 June 2022 Pages: 805 - 813
Joint Task Force Core Competency Framework Adoption Process at a National Level: A Survey of Ukrainian-Based Clinical Research Professionals V. Ye. DobrovaO. S. PopovO. M. Proskurnia Original Research 02 July 2022 Pages: 814 - 821
Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to the South African Health Products Regulatory Authority (SAHPRA) Lerato MoetiMadira LiteduJacques Joubert Original Research 27 July 2022 Pages: 822 - 838
A Comparison of Safety Information in Drug Labeling at the Initial Approval of New Drugs Approved Both in Japan and the United States Yuko HoshinoMamoru Narukawa Original Research 25 July 2022 Pages: 839 - 847
Building from Patient Experiences to Deliver Patient-Focused Healthcare Systems in Collaboration with Patients: A Call to Action Karlin SchroederNeil BertelsenNicholas Brooke Original Research Open access 19 July 2022 Pages: 848 - 858
Over-Prescription of the Imidazoline Receptor Agonists: Evidence for Restriction of the Therapeutic Indication Rimas JankūnasDiana RinkūnienėDonatas Stakišaitis Original Research 30 July 2022 Pages: 859 - 866
Retraction Note to: Seasonal and Secular Periodicities Identified in the Dynamics of US FDA Medical Devices (1976–2020): Portends Intrinsic Industrial Transformation and Independence of Certain Crises Iraj Daizadeh Retraction Note 24 May 2022 Pages: 867 - 867
