Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency’s structure and stakeholder interactions. ...more
On March 15, 2024, FDA published a white paper titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” (the AI White Paper) on the use of artificial intelligence (AI) across the...more
Liability exposure and shields for vaccine developers - As the number of COVID-19 cases continues to rise every day, efforts to develop vaccines across the globe have hit record speeds. In the U.S., the U.S. Food and Drug...more