Day: October 24, 2024

FDA’s top scientists published a review article in the Journal of American Medical Association (JAMA) reviewing the various uses of Artificial Intelligence (AI) and the regulatory trends and expectations. FDA acknowledges several current and potential uses of AI in drug development and clinical research, making these processes more efficient and precise.  In drug development, AI … Read more

Clinical trials require controls and robust informed consent. However, ethicists argue if the one-size-fits-all approach should be customized to the perceived risk of a given trial. Should the trail risk be determined by the regulators and the information shared with the participants via the informed consent be reduced for lower-risk trials to encourage more investigator … Read more