The Regulatory Affairs Support Program supports the work of the Office of Regulatory Affairs (ORA) in the Division of Microbiology and Infectious Diseases (DMID). ORA provides regulatory oversight in the conduct of human subjects research funded by DMID and ensures compliance with federal regulations and policies as well as National Institutes of Health, NIAID, and DMID policies.
With limited exception, DMID sponsors the Investigational New Drug (IND) and Investigational Device Exception (IDE) for the product being tested in DMID-sponsored clinical trials. ORA serves as the authorized sponsor representative for DMID-held INDs and IDEs, and as the authorized representative in all communications with the Food and Drug Administration. The Regulatory Affairs Support Program assists with filing INDs/IDEs and pre-INDs/IDEs by collecting needed data and documents, providing expert consultation for, e.g., auditing, performing technical review of applications, and preparing reports. When necessary, all proper agreements are put in place to ensure users proprietary rights, and confidentiality is guaranteed.