FDA Plans Pilot Projects for Drug Supply Chain Security Act
Under the Drug Supply Chain Security Act (DSCSA), FDA is required to establish pilot project(s) to “explore and evaluate methods to enhance the safety and security of [the] supply chain,” the agency noted in a request for proposals in July 2015. The agency recently awarded a contract to consulting firm USDM Life Sciences, who will work with DSCSA consultancy RC Partnersand event management firm The Clarion Group. The three companies were designated to work together for approximately eight months to deliver and execute the FDA program for the pharmaceutical distribution supply chain. The project will include developing the structure of the pilot program, including a schedule and enrollment process for potential participants, and implementing and monitoring the pilot project.