UNC, Duke, Wake Forest, and RTI launch regulatory website
The new ReGARDD.org website (hosted and maintained by affiliates at UNC, Duke, Wake Forest, and RTI) shares current best practices for preparing IND and IDE submissions to the FDA.
The ReGARDD team is comprised of regulatory affairs specialists and experts from these institutions that receive funding from the NIH Clinical and Translational Science Awards (CTSA) Program.
The website includes up-to-date federal regulations, protocol and submission templates, and in-depth guidance concerning drug and device clinical research pathways.