On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines and other medical products...more
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval Program, including a focus on product withdrawal and requirements for ongoing confirmatory...more
In response to an outbreak of the H5N1 strain of bird flu among dairy cows in at least 15 states, the U.S. Department of Agriculture (USDA) issued a new federal order (the Order) requiring dairy farms and other entities...more
On Sept. 18, 2024, the U.S. Food & Drug Administration (FDA) issued a final guidance document titled “Conducting Clinical Trials With Decentralized Elements, Guidance for Industry, Investigators, and Other Interested...more
Over 200 fellow healthcare leaders joined the 17th Annual Healthcare Finance and Growth conference for interactive programming discussing the latest developments in the industry and the challenges the industry faces in 2024...more