Newsletter - October 24, 2024
FDA Summarizes Plans to Regulate for AI Devices
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...Read More
Should Minimal Risk Clinical Trials Require a Different Informed Consent?
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...Read More
FDA Summarizes Plans to Regulate for AI Devices
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...Read More
Should Minimal Risk Clinical Trials Require a Different Informed Consent?
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...Read More