 The pandemic has highlighted the need for academic medical centres to have strong regulatory support systems in place to ensure timely access to investigational agents and all medical devices. The Food and Drug Administration's use of expanded access, emergency use authorisations, and clinical trials as pre-approval pathways has been essential in providing access to novel treatments during the pandemic. Academic medical centres with regulatory support units have been able to provide valuable assistance to clinicians in navigating these pathways. These units have also had to make significant adjustments to their operations to meet the needs of the pandemic, including the development of electronic submission capabilities for food and drug administration documents, reallocations of resources, and the acquisition of new skills. This article was authored by Misty Gravelin, Gene Wright, Emmy Blair Holden, and others.