Articles and Blogs

On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) finalized “Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. The Final Guidance reflects the FDA’s recommendations on informed consent and the regulatory requirements in place to... 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