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FDA, MHRA and Health Canada Jointly Publish Guiding Principles for Predetermined Change Control Plans for ML-Enabled Medical Devices

Harnessing digital technologies for universal health

FDA Updates Electronic Systems in Clinical Investigations Guidance

The FDA updated draft guidance for Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers which revamps recommendations from 2017 on the requirements of 21 CFR Part 11 and use of technologies in clinical investigations.

FDA Revamps Guidance Concerning Use of Electronic Systems, Records, and Signatures in Clinical Investigations | Nelson Mullins Riley & Scarborough LLP

The U.S. Food and Drug Administration (FDA) has published updated draft guidance for industry, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical.

FDA M-CERSI AI workshop highlights future FDA comment period on AI in drug development | Hogan Lovells

The U.S. Food and Drug Administration (FDA) – in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) – recently hosted a.