Newsletter - August 17, 2023
FDA’s New Post-Market Diversity Expectations
Despite extensive advocacy from the FDA, most pre-approval clinical trials lack diversity owing primarily to the unwillingness of certain segments of the population to participate in clinical trials. However, once a drug is approved by the FDA, its use is more diverse and representative of the demographic distribution...Read More
FDA Requirements for Using Off-The-Shelf Software in New Medical Devices
In the dynamic landscape of medical device innovation, the utilization of off-the-shelf (OTS) software has become a cornerstone for rapid development and enhanced functionality. However, it is hard for the developers of devices to include most details about the OTS software, the kind of which would...Read More
FDA’s New Post-Market Diversity Expectations
Despite extensive advocacy from the FDA, most pre-approval clinical trials lack diversity owing primarily to the unwillingness of certain segments of the population to participate in clinical trials. However, once a drug is approved by the FDA, its use is more diverse and representative of the demographic distribution...Read More
FDA Requirements for Using Off-The-Shelf Software in New Medical Devices
In the dynamic landscape of medical device innovation, the utilization of off-the-shelf (OTS) software has become a cornerstone for rapid development and enhanced functionality. However, it is hard for the developers of devices to include most details about the OTS software, the kind of which would...Read More
