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Therapeutic Innovation & Regulatory Science|January 9, 2023
Risk-Based Monitoring in Clinical Trials: 2021 UpdateAmy Adams, Anina Adelfio, Brian Barnes, et al.Therapeutic Innovation & Regulatory Science|June 23, 2021
Practical Considerations and Recommendations for Master Protocol Framework: Basket, Umbrella and Platform TrialsChengxing Cindy Lu, Xiaoyun Nicole Li, Kristine Broglio, et al.Therapeutic Innovation & Regulatory Science|June 18, 2021
Measuring What Matters for Children: A Systematic Review of Frequently Used Pediatric Generic PRO InstrumentsTasneem Arsiwala, Nuzhat Afroz, Kattayoun Kordy, et al.Therapeutic Innovation & Regulatory Science|July 6, 2021
Ascertaining Nonfatal Endpoints in Clinical Trials: Central Adjudication Versus Patient Insurance ClaimsEric L Eisenstein, Meredith N Zozus, Sharon F Terry, et al.Therapeutic Innovation & Regulatory Science|May 20, 2022
Health Equity in Pediatric Drug Development: Translating Aspiration into OperationMorenike Oluwatoyin Folayan, Magda Conway, Carolyn Russo, et al.Therapeutic Innovation & Regulatory Science|May 13, 2022
How Many Clinical Trials Exist that Have Adopted Selective Safety Data Collection? NEJM Literature Search Results: The Possibility of Harmonizing the ICH E19 GuidelineYuki Yamatani, Hiroyuki Saeki, Risa Tanaka, et al.Therapeutic Innovation & Regulatory Science|July 22, 2021
Laboratory-Developed Tests: Design of a Regulatory Strategy in Compliance with the International State-of-the-Art and the Regulation (EU) 2017/746 (EU IVDR [In Vitro Diagnostic Medical Device Regulation])Folker Spitzenberger, Jaimin Patel, Inga Gebuhr, et al.Therapeutic Innovation & Regulatory Science|May 9, 2022
Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims : Let's Share the Success Stories to Move the Industry ForwardFlorence D Mowlem, Pamela Tenaerts, Chad Gwaltney, et al.Therapeutic Innovation & Regulatory Science|July 15, 2021
Government Pharmaceutical Development to Address High Prices: Challenges AheadJonathan J DarrowTherapeutic Innovation & Regulatory Science|April 20, 2021
Integrated Analytical Framework for the Development of Artificial Intelligence-Based Medical DevicesHirokazu Arima, Shingo KanoPageof 165