9/27/2023 Updates Meeting

Written By PIcc Alliance

Steering Committee Series

Watch the recording from the meeting.

Download the slides from the meeting here

FDA

Learn more here

  • Guidance: Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry (download .pdf)

  • Recruiting Pathologists to Truth sTILs (link)

  • CBER and CDER RWE Program (link)

  • Digital Health Frequently Asked Questions (FAQs) (link)

  • DICOM for Digital Pathology highlighted on digital pathology products (link)

  • Article: AI–Enabled Medical Devices and Diagnostics: Statistical Challenges and Opportunities from a Regulatory Perspective (link)


FOCR

  • Future in Focus: Digital Pathology in Oncology Drug Development hosted on September 27. Watch here

  • White paper: Supporting the Application of Computational Pathology in Oncology (download .pdf)

MDIC

  • Join us at MXR2023 (link)

FNIH

  • Foundation for the National Institutes of Health Biomarkers Consortium introduction to PIcc by Althea Lang, PhD, PMP (download slides)

Resources & Publications

  • Hart et al. Initial Interactions with the FDA on Developing a Validation Dataset as a Medical Device Development Tool (link)

  • Kimberly A. Urbanek & Kyle J. Graham. Workplace Violence Prevention Handbook from the Crisis Prevention Institute (download .pdf)

  • How to obtain a Small Business Designation (SBD) with the FDA (download .pdf)

  • Richardson et al. Noninterpretive Uses of Artificial Intelligence in Radiology (download .pdf)

  • Lu et al. Learning under Concept Drift: A Review (download .pdf)

  • David J. Carr & H. Gilbert Welch. Assessing the Clinical Utility of Liquid Biopsies Across 5 Potential Indications From Therapy Selection to Population Screening A Review (download .pdf)

  • Ahluwalia et al. The Subgroup Imperative: Chest Radiograph Classifier Generalization Gaps in Patient, Setting, and Pathology Subgroups (download .pdf)

  • Merel Huisman & Gerjon Hannink. The AI Generalization Gap: One Size Does Not Fit All (download .pdf)

  • Hoskinson et al. Delayed gut microbiota maturation in the first year of life is a hallmark of pediatric allergic disease (download .pdf)

  • Friends of Cancer Research White Paper: Supporting the Application of Computational Pathology in Oncology (download .pdf)

  • Cheng et al. Accurate proteome-wide missense variant effect prediction with AlphaMissense (download .pdf)

  • O’Conner et al. Defining rare conditions in the era of personalized medicine (download .pdf)

PIcc Alliance
Previous

12/06/2023 Updates Meeting
Next

8/30/2023 Updates Meeting