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What Is Risk Management in Healthcare?
The imperative for regulatory oversight of large language models (or generative AI) in healthcare
CDRH Regulatory Science Priorities
Regulatory Considerations on the use of Machine Learning based tools in Clinical Trials
Regulatory Science Tools Reduce Risk in New Medical Devices
CODE-EHR best-practice framework for the use of structured electronic health-care records in clinical research - The Lancet Digital Health
Accelerating med tech: FDA catalog of research tools showcases agency's commitment to innovators
Pilot III - Presentation 'Regulatory Support to Spanish Academia from STARS Core to Comprehensive Curriculum' - Stars
FDA's Catalog of Regulatory Science Tools - EMMA International
Making Sense of Your Self-Assessment, Science
Regulatory Science – An Underappreciated Component of Translational Research: Trends in Pharmacological Sciences
USA Overview of the Medical Device Market (video)
O'Leary's Blog - Regulatory considerations for digital surrogate endpoint response biomarkers
The evolving regulatory landscape in regenerative medicine - ScienceDirect
Evolving regulatory perspectives on digital health technologies for medicinal product development