Regulatory Review Support

The U.S. Food and Drug Administration (FDA) is a scientific regulatory agency that employs more than 10,000 scientific, technical, and support staff who are responsible for protecting and promoting the public health in the United States. One of the ways that FDA will advance its broad public health mission is by working to transform administrative systems and infrastructure to support FDA operations. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription, and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics. This is accomplished through the regulatory review of sponsor submissions in a supportive infrastructure that allows for tools, technologies, and processes to be integrated and use standardized data, enabling modern review processes and capabilities. The scope of this contract is the complete range of activities necessary to promote the efficient and technologically advanced review and analysis of standardized data for regulatory review of sponsor submissions at the FDA. The contract will enable reviewers to assess product safety, efficacy, and quality by providing the capability to ask sponsors more in-depth questions, devote more time to team discussions, and achieve greater transparency and consistency in decision making and documentation. These capabilities shall be enabled through coordinated use of tools and technologies across all review disciplines, as well as organizational initiatives (e.g. change management, communications, training, knowledge management, data management, and collaboration). The operation/maintenance of and further developments/ enhancements specific to the Script Launcher and CSC Review Portal applications are explicitly excluded from the scope of this contract. In no case will the FDA fund the operation/maintenance of or continued developments/enhancements specific to these two applications under this contract.