9/27/2023 Updates Meeting
Steering Committee Series
Watch the recording from the meeting.
FDA
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)