Newsletter - November 2, 2023
How Does the Executive Order for AI Affect Digital Health Products?
With a wide-ranging and far-reaching Executive Order signed this week by President Biden, the administration is implementing several requirements from developers of products containing Artificial Intelligence (AI) technologies that would affect digital health products, somewhat. The order is primarily focused...Read More
FDA Acceptance of The Data from Traditional Chinese Medicine for Heart Health
A recent publication of a placebo-controlled clinical trial in China with a Traditional Chinese Medicine (TCM) product showed signification benefits in the management of Acute ST-segment elevation myocardial infarction (STEMI). However, what would be the likelihood of FDA acceptance of clinical data...Read More
How Does the Executive Order for AI Affect Digital Health Products?
With a wide-ranging and far-reaching Executive Order signed this week by President Biden, the administration is implementing several requirements from developers of products containing Artificial Intelligence (AI) technologies that would affect digital health products, somewhat. The order is primarily focused...Read More
FDA Acceptance of The Data from Traditional Chinese Medicine for Heart Health
A recent publication of a placebo-controlled clinical trial in China with a Traditional Chinese Medicine (TCM) product showed signification benefits in the management of Acute ST-segment elevation myocardial infarction (STEMI). However, what would be the likelihood of FDA acceptance of clinical data...Read More