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Data Governance

Navigating the Regulatory Horizon: Predicting FDA Guidance for 2024 and Staying Nimble

January 24, 2024
Data Governance
AI
Regulatory Analysis

As we step into 2024, medical device manufacturers are poised for a year of regulatory evolution, guided by the FDA's upcoming guidance documents.

Striking the Balance: Safeguarding Clinical Trials with AI

January 24, 2024
Data Governance
AI
Regulatory Analysis

This is the first post in a series on using AI/ML in drug development, considerations for benefit-risk analysis, and potential mitigations to support responsible AI.