Clarity, Compliance & Care: Where Compassion Meets Compliance

The 21st Century Cures Act outlines requirements for posting your Expanded Access policy on your website. In addition to posting the sponsor’s EA policy on the corporate website, the EA availability must be posted on ClinicalTrials.gov, and can also be registered at the FDA’s Reagan-Udall Foundation website. We provide a comprehensive overview of the requirements and best practices for developing an Expanded Access policy.