Day: October 3, 2024

Electronic medical records and other electronic systems are ubiquitous sources of the source data for clinical trials. There is confusion and misinformation about the FDA requirements from such data particularly in pragmatic trials where the clinics participating in the clinical trial also provide health care services. FDA’s new guidance on the topics answers many common … Read more

The submission and tracking portal maintained by the Center for Devices (CDRH) at the FDA is an enhanced tool for not only the electronic submission of almost all device applications but also for tracking the progress of the review and interacting with the FDA reviewers. This week, the FDA added more functions to it. The … Read more