The DAIDS Regulatory Affairs Branch (RAB) and The DAIDS RSC Regulatory Team
DAIDS RAB is a branch of DAIDS within the Office of Policy in Clinical Research Operations (OPCRO). RAB is responsible for regulatory strategy across the DAIDS programs. RAB performs regulatory management and surveillance and is the official DAIDS liaison to the U.S. FDA for clinical trials sponsored/funded by DAIDS. RAB members sign the Form FDA 1571 for DAIDS-sponsored INDs.
The DAIDS RSC Regulatory Team works closely with DAIDS RAB and provides support by reviewing protocol documents for regulatory compliance, and preparing and filing new Investigational New Drug Applications (INDs) and amendments to existing INDs in compliance with the procedural and substantive requirements of 21 CFR 312. Examples of submissions to the FDA include original IND Applications, Annual Reports, Safety Reports, and Responses to FDA Requests for Information.