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RF Quarterly,  March 2023
Patient-focused regulatory practice

Welcome to the March issue of RF Quarterly, which takes a look at patient-focused regulatory practice and includes articles on patient-reported outcomes in regulatory decision making; real-world evidence and postmarket surveillance data; generating evidence for racial and ethnic minorities in oncologic drug development; structured, patient-focused benefit-risk assessment; and the role of the high-performance integrated virtual in research using patient-generated data.

Table of Contents

1    Introduction
          Flora Sandra Siami, MPH   •  Stephen C. Weber, MD
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4   The evolution and use of patient-reported outcomes
      in regulatory decision making
         Stephen C. Weber, MD
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11  Real-world evidence and postmarket surveillance data: Are they the same thing?
           Kasey Sands, PhD, MSN, RN • Joy Frestedt, PhD, CPI, RAC, FRAPS, FACRP
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23  Generating evidence for racial and ethnic minorities during development of oncologic therapeutics
           Lola Fashoyin-Aje, MD, MPH • Lea Ann Browning-McNee, MS •
           Jessica Boehmer, MBA • Richard Pazdur, MD • Susan C. Winckler, RPh, Esq
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31  Industry implementation of structured, patient-focused benefit-risk assessment
           Charles Garrigan, MS, MBA  • Bennett Levitan, MD, PhD
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43  Enhancing collaboration, access, and research using patient-generated data
           Laura E. Gressler, MS, PhD • Art Sedrakyan, MD, PhD
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• Global health and regulatory authorities (June)
• Leadership (September; print issue to 2023 Convergence)
• 2023 RAPS Convergence (December)

• Artificial intelligence (December 2022)
• Regulatory strategy (September 2022)
• Regulatory history (June 2022)
• Software as a medical device (April 2022)
• Selected takeaways RAPS Convergence 2021 (December 2021)
• Quality and compliance (September 2021)
• Artificial intelligence in regulatory affairs (June 2021)
• Global clinical trials (March 2021, inaugural issue)

To contribute, email Renee Matthews, Senior Editor, at rmatthews@raps.org. 

For more information, see: Guidelines for Authors • 2023 Editorial Calendar

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