The U.S. Senate is out of session this week, and all action is expected to take place in the U.S. House of Representatives following the release of a package containing the final four appropriations bills. The text of the...more
Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders....more
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