An FDA Analysis of Inspected Entities After Receiving Official Action Indicated Letters for Good Clinical Practice Violations Miah JungRachelle M. SwannFaranak Jamali Original Research Open access 08 June 2021 Pages: 907 - 917
Biennial Analysis of Medication Guide Length and Estimated Readability for New Molecular Entity Drugs, 2011–2017 Paul R. JonesElisabeth J. WaltherBryon M. Pearsall Original Research 10 May 2021 Pages: 918 - 925
Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial Len RosenbergHugh LevauxAmy Burd Original Research Open access 16 May 2021 Pages: 926 - 935
Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action Maria Cavaller-BellaubiStuart D. FaulknerElisa Ferrer Original Research Open access 10 May 2021 Pages: 936 - 953
Evaluating Metrics Applied to the Medical Science Liaison (MSL) Role: A Survey-Based Study of Canadian MSL Leaders Munaza SaleemLisa CesarioAndrew Chilelli Original Research Open access 04 May 2021 Pages: 954 - 965
Investigator Initiated Clinical Trials (IICTs): A Systematic Search in Registries to Compare the Czech Republic and Portugal in Terms of Funding Policies and Scientific Outcomes C. MadeiraL. HořavováE. C. Monteiro Original Research Open access 18 May 2021 Pages: 966 - 978
Cutting Through the “Gray Area”: An Analysis of the IBC Regulatory Oversight of Applications of CRISPR Technology in Clinical Research Westley F. Weiss Analytical Report 18 May 2021 Pages: 979 - 983
Implementation of ICH E9 (R1): A Few Points Learned During the COVID-19 Pandemic Yongming QuIlya Lipkovich Analytical Report 13 May 2021 Pages: 984 - 988
Addressing Bias in Responder Analysis of Patient-Reported Outcomes Joseph C. CappelleriRichard Chambers Original Research Open access 27 May 2021 Pages: 989 - 1000
Proof of Concept: Drug Selection? Or Dose Selection? Thoughts on Multiplicity Issues Qian H. LiQiqi DengNaitee Ting Original Research 24 May 2021 Pages: 1001 - 1005
Characterizing Pain Points in Clinical Data Management and Assessing the Impact of Mid-Study Updates Beth HarperZachary SmithKen Getz Original Research 07 May 2021 Pages: 1006 - 1012
Correction to: Characterizing Pain Points in Clinical Data Management and Assessing the Impact of Mid-Study Updates Beth HarperZachary SmithKen Getz Correction 17 May 2021 Pages: 1013 - 1013
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 Belkis RomeuYaquelín RodríguezSilvia Bendiner Commentary 03 May 2021 Pages: 1014 - 1018
The Use of External Controls in FDA Regulatory Decision Making Mahta JahanshahiKeith GreggSharon Sakai Review Open access 20 May 2021 Pages: 1019 - 1035
Oncology Products in the European Union: An Analysis of Regulatory Approvals with a CHMP Oral Explanation Alexandra OgerAimad TorquiSacha Wissink Original Research 26 May 2021 Pages: 1036 - 1044
Innovation Pathways in the NHS: An Introductory Review Anmol AroraAndrew WrightMatthew Seah Review Open access 19 May 2021 Pages: 1045 - 1058
Patient Engagement Initiatives in Clinical Trials: Recent Trends and Implications Shalome SineAnnick de BruinKenneth Getz Original Research Open access 07 June 2021 Pages: 1059 - 1065
Clinical Quality Considerations when Using Next-Generation Sequencing (NGS) in Clinical Drug Development Timothé MénardAlaina BarrosChristopher Ganter Review Open access 27 May 2021 Pages: 1066 - 1074
Factors Influencing Classifications of Safety Specifications in a Risk Management Plan for Antineoplastic Agents Approved in Japan: A Review and Descriptive Analysis Asami EzakiAkihiro HirakawaYoshiaki Uyama Original Research 09 June 2021 Pages: 1075 - 1081
Measuring What Matters for Children: A Systematic Review of Frequently Used Pediatric Generic PRO Instruments Tasneem ArsiwalaNuzhat AfrozFrancesco Patalano Original Research Open access 17 June 2021 Pages: 1082 - 1095
Dissolution Profiles of Generic Products in Dissolution Media Defined by Japanese Guidelines for Bioequivalence Studies Eiji KajiwaraHaruki KamizatoMayumi Shikano Original Research 07 June 2021 Pages: 1096 - 1100
Prescribing Information for Antihypertensive Medications Lacks Dose-Specific Blood Pressure Response Ruchi VyasCatherine E. Cooke Letter to the Editor 14 June 2021 Pages: 1101 - 1102
Government Pharmaceutical Development to Address High Prices: Challenges Ahead Jonathan J. Darrow Commentary 14 July 2021 Pages: 1103 - 1105