Global Medtech Guidance Tracker: October 2022
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-six documents have been posted on the tracker since its last update.
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FDA Takes Aim At Reducing Health Disparities Through Breakthrough Devices Program
Proposed updates to the US FDA’s breakthrough devices program guidance would help to clarify how the program may be applicable to devices that treat and diagnose diseases that disproportionately affect certain populations.
EMA To Explain How Trial Transparency & Data Redaction Can Live Together
The European Medicines Agency is working to align the redaction and data anonymization principles underpinning two EU clinical trial transparency initiatives to ensure consistency in disclosure requirements.
ICH Consults On Modernized GCP Principles To Make Clinical Trials More Efficient
The International Council for Harmonisation has issued updated Good Clinical Practice principles to accommodate new clinical trial and data types.