Articles and Blogs

On April 29, 2026, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a Request for Information (“RFI”) seeking stakeholder input on a proposed pilot program evaluating the use of artificial intelligence (“AI”) to optimize early-phase clinical trials. The initiative is intended to assess how AI-enabled technologies “can improve efficiency, speed and... READ MORE

On April 28, 2026, the U.S. Food and Drug Administration (“FDA”) announced additional steps in its ongoing initiative to advance real-time clinical trial approaches, including proof-of-concept studies and a request for information supporting a planned pilot program focused on real-time or near-real-time clinical trial data capture and review (the “Announcement”). FDA Commissioner Marty Makary,... READ MORE

Earlier this year, the U.S. Food and Drug Administration (“FDA”) announced the availability of new draft guidance titled “Use of Data Monitoring Committees in Clinical Trials” (“Draft Guidance”). When finalized, the Draft Guidance will supersede the March 2006 guidance titled “Establishment and Operation of Clinical Trial Data Monitoring Committees.” A Data Monitoring Committee (“DMC”)... READ MORE

On June 6, 2023, the U.S. Food and Drug Administration (“FDA”) released draft guidance (“Draft Guidance”) updating Good Clinical Practices (“GCPs”) recommendations for interventional clinical trials involving human subjects. The Draft Guidance, which is aimed at enabling the incorporation of rapidly evolving technological and methodological innovations into clinical trials, is adapted from the International... READ MORE

Friday, April 17 Recap Note – ​We believe this is the most up-to-date information available at this time, but it is subject to change ​as circumstances warrant. Also, all finalized resources can be found ​on the COVID-19 ​Resource ​Center page ​of Hall Render’s website.​ Second Tranche of CARES Funds Delayed Reports out of HHS today indicate... READ MORE

On March 18, 2020, the FDA issued FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic that provides guidance for Sponsors, Clinical Investigators and Institutional Review Boards (“IRBs”) on how to address disruptions in the conduct of clinical trials (“Trials”) as a result of COVID-19. COVID-19 Disruptions to Clinical Trials... READ MORE