FDA’s New Guidance for Industry Addressing Evaluation of the Safety of New Drugs for Improving Glycemic Control: A Case Study in Regulatory Science J. Rick Turner Editor Emeritus Editorial 21 October 2020 Pages: 1 - 5
Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative J. Stephen MikitaJules MitchelSara B. Calvert Original Research Open access 22 June 2020 Pages: 6 - 18
Benchmarking Patient Recruitment and Retention Practices Mary Jo LambertiZachary SmithKenneth Getz Original Research 16 June 2020 Pages: 19 - 32
Determining Minimum Wear Time for Mobile Sensor Technology Marie McCarthyDenise P. BurySusan Wong Analytical Report 25 June 2020 Pages: 33 - 37
Choosing a Mobile Sensor Technology for a Clinical Trial: Statistical Considerations, Developments and Learnings Colleen RussellMarie McCarthySusan Wong Analytical Report 18 June 2020 Pages: 38 - 47
Alternative New Mono-scaled Quantitative Benefit–Risk Assessment of Human Papillomavirus Vaccine in Japan Tomoko MatsumotoNaoki MatsumaruKatsura Tsukamoto Original Research 22 June 2020 Pages: 48 - 55
Spatial-Cluster Signal Detection in Medical Devices Using Likelihood Ratio Test Method Tingting HuLan HuangRam Tiwari Original Research 22 June 2020 Pages: 56 - 64
Policy of Multisource Drug Products in Latin America: Opportunities and Challenges on the Application of Bioequivalence In Vitro Assays Claudia Miranda-Pérez de AlejoAlexis Aceituno ÁlvarezMiguel Ángel Cabrera-Pérez Original Research 29 June 2020 Pages: 65 - 81
Factors Related to Conversion from Accelerated to Full Approval for Drugs Approved in the United States Between 2000 and 2016 Koji IrisawaMasayuki KanekoMamoru Narukawa Original Research 29 June 2020 Pages: 82 - 89
Bridging the Gap Between RCTs and RWE Through Endpoint Selection Robert J. LoCasaleChris L. PashosSajan Khosla Commentary Open access 06 July 2020 Pages: 90 - 96
Correction to: Bridging the Gap Between RCTs and RWE Through Endpoint Selection Robert J. LoCasaleChris L. PashosSajan Khosla Correction 30 October 2020 Pages: 97 - 97
Disagreements Between FDA and its Oncologic Drugs Advisory Committee (ODAC) Ariana Ayon VerduzcoKwadwo Yeboah Review 06 August 2020 Pages: 98 - 110
Collection of Post-treatment PRO Data in Oncology Clinical Trials J. Jason LundyCheryl D. CoonVivek Pawar Commentary Open access 08 July 2020 Pages: 111 - 117
Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice Céline RodierMagda BujarLawrence Liberti Original Research Open access 02 July 2020 Pages: 118 - 128
Predicting Regulatory Product Approvals Using a Proposed Quantitative Version of FDA’s Benefit–Risk Framework to Calculate Net-Benefit Score and Benefit–Risk Ratio Stephen SunSuzanne HeskeJean Wimmer Original Research Open access 08 July 2020 Pages: 129 - 137
Rebranding Gout: Could a Name Change for Gout Improve Adherence to Urate-Lowering Therapy? Matthew J. ColeshillEindra AungRichard O. Day Commentary 13 July 2020 Pages: 138 - 141
Exploring Completeness of Adverse Event Reports as a Tool for Signal Detection in Pharmacovigilance Inyoung LeeJeremy D. JokinenTodd A. Lee Original Research 27 July 2020 Pages: 142 - 151
Mobile Applications (Apps) to Support the Hepatitis C Treatment: A Systematic Search in App Stores Aline Teotonio RodriguesCamila Tavares SousaTácio de Mendonça Lima Review 22 July 2020 Pages: 152 - 162
The CECMED Office of Innovation: A Core Initiative to Bolster Novel Pharmaceutical Products-The Cuban Approach Belkis RomeuRafael Perez Cristiá Original Research 27 July 2020 Pages: 163 - 169
FDA’s Benefit–Risk Framework for Human Drugs and Biologics: Role in Benefit–Risk Assessment and Analysis of Use for Drug Approvals Leila LackeyGraham ThompsonSara Eggers Original Research 10 August 2020 Pages: 170 - 179
Feasibility of a Hybrid Risk-Adapted Monitoring System in Investigator-Sponsored Trials in Cancer Sinae KimYunJung KimTae Won Kim Original Research 18 August 2020 Pages: 180 - 189
Using Statistical Modeling for Enhanced and Flexible Pharmacovigilance Audit Risk Assessment and Planning Min ZouYves BarmazTimothé Ménard Original Research Open access 17 August 2020 Pages: 190 - 196
Methods for Employing Information About Uncertainty of Ascertainment of Events in Clinical Trials Yiming ChenJohn LawrenceNorman Stockbridge Original Research 01 September 2020 Pages: 197 - 211
Drivers of Start-Up Delays in Global Randomized Clinical Trials Jennifer LaiLeila ForneyKit N. Simpson Original Research 21 September 2020 Pages: 212 - 227
Impact of Real-World Data on Market Authorization, Reimbursement Decision & Price Negotiation Alfredo Aram PuliniGabriela Martins CaetanoGregory Katz Review 28 August 2020 Pages: 228 - 238
Unicorn Poo and Blessed Waters: COVID-19 Quackery and FDA Warning Letters Katrina A. Bramstedt Original Research 01 October 2020 Pages: 239 - 244
Ensuring Black Lives Matter in Drug Development William E. FitzsimmonsClara Okorie-Awé Letter to the Editor 22 October 2020 Pages: 245 - 246
Patient Contribution to the Development and Safe Use of Medicines During the Covid-19 Pandemic Peter J. PittsFrançois Houÿez Letter to the Editor 27 October 2020 Pages: 247 - 249
