Apr 25, 2023 | White Paper
Decentralized clinical trials (DCTs) are becoming more and more popular as a means of improving patient access and participation, reducing costs, and increasing efficiency. However, DCTs also present unique challenges in terms of data collection and management,...
Apr 10, 2023 | White Paper
If we can’t “engineer out” bias from the design and development of AI software applications, and if we can’t remove human bias from the use or application of the software, then what tools do we have to manage bias in and around AI? How do the FDA's Good Machine...
Apr 3, 2023 | White Paper
Being in unchartered territory within a regulated space can be scary! Yet, it is in unchartered territory that new breakthrough technologies and treatments are found. The FDA Breakthrough Devices Program can alleviate some of the worry. The FDA is committed to a high...