Articles and Blogs

On February 10, 2023, the Office for Human Research Protections (“OHRP”) announced that the COVID-19 single institutional review board (“IRB”) exception determination will expire on May 11, 2023, consistent with the expiration of the COVID-19 Public Health Emergency (“PHE”). With the expiration of the COVID-19 single IRB exception determination (the “COVID-19 Exception Determination”), research... 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