Research Involving:
- ChatGPT/ Large Language Models (LLM)/ Artificial Intelligence (AI)
- Expanded Access to Unapproved Drugs for Treatment
- Investigational New Drugs and Biologics (IND)
- Investigational Devices (IDE)
- Mobile Medical Applications
- Significant vs. Non-Significant Risk Devices
Resources
FDA
- Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies
- Is Your Clinical Decision Support Software a Device? The Clinical Decision Support Software guidance describes the regulatory approach to Clinical Decision Support (CDS) software functions. The decision tree offers a general and illustrative summary of this guidance.
- UCSF