There are new requirements under the Drug Supply Chain Security Act (DSCSA) for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Some requirements began in November 2014 and several key requirements begin at various stages in 2015. The new requirements, development of standards, and the system for product tracing will continue to be phased in over the next nine years. FDA will continue working with trading partners and other stakeholders to effectively implement the new requirements.
New Drugs to Market – October Update
Phillip Berry | Oct 25th, 2024
The Food and Drug Administration (FDA) approved three novel drug therapies in October. One of those therapies, Hympavzi (marstacimab-hncq), is a medication indicated for the treatment of patients with Hemophilia A and Hemophilia B. Hympavzi utilizes a new pathway to help reduce the risk of bleeding episodes in patients with Hemophilia, a disease that impacts … more »