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Digital Health Regulation: A Comparative Study of the EU and the USA 03 Sep 2023 - 13 min read

Digital Health Regulation: A Comparative Study of the EU and the USA

Healthcare technologyRegulatory news

In the last decade, healthcare technology has advanced to a significant level. Many fields, such as cardiology, home care, dentistry,…

The Future of Clinical Research 02 Sep 2023 - 20 min read

The Future of Clinical Research: The Regulatory Perspective

Healthcare technologyRegulatory news

The clinical research enterprise is at a crossroads. As we peer into the future of clinical research, the regulatory perspective…

AI in Healthcare: Navigating Regulatory Pathways in Europe and the USA 23 Jul 2023 - 15 min read

AI in Healthcare: Navigating Regulatory Pathways in Europe and the USA

Regulatory news

Over the past couple of years, we have seen the greater involvement of AI (Artificial Intelligence) in every possible aspect…

FDA Draft Guidance on GCPs: Steps to Innovate Clinical Trials 04 Jul 2023 - 7 min read

FDA Draft Guidance on GCPs: Steps to Innovate Clinical Trials

Regulatory news

The FDA is bringing to the table draft recommendations on innovative trial designs and health technologies to be incorporated into…