Newsletter - October 3, 2024
Electronic Systems in Clinical Trials: FDA Guidance
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. Read More
FDA Expands the Functionalities of the CDRH Portal
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...Read More
Electronic Systems in Clinical Trials: FDA Guidance
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. Read More
FDA Expands the Functionalities of the CDRH Portal
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...Read More