The Open Hand Initiative: Advancing Real-World Evidence in Medical Device Approvals
The Open Hand Initiative: Facilitating the Use of Real-World Evidence in Regulatory Submissions Through Collaboration and Transparency
The Open Hand Initiative, led by MDIC in collaboration with the FDA and industry partners, showcases a groundbreaking approach to using real-world data (RWD) and real-world evidence (RWE) in regulatory submissions. Piloted during the COVID-19 pandemic, this initiative brought together stakeholders to openly share insights and address challenges in transitioning SARS-CoV-2 diagnostics from Emergency Use Authorization (EUA) to full FDA approval.
By fostering transparency and collaboration, the Open Hand Initiative highlights best practices for leveraging high-quality RWD to generate RWE and streamline regulatory decision-making. Discover how this innovative model is shaping the future of medical device approvals and advancing patient care.
The Open Hand Initiative: Facilitating the Use of Real-World Evidence in Regulatory Submissions Through Collaboration and Transparency was published in the Clinical Pharmacology & Therapeutics Journal in Spring 2024.