About Us

The Regulatory Toolbox Working Group was established in 2019 as an NIH-wide collaboration to provide regulatory information and guidance to the FDA regulated community within the NIH Intramural Research Program. Members include regulatory professionals representing 13 Institutes and Centers across NIH. Our goal is to demystify the IND and IDE application process and highlight personnel resources available to make the process easier.

NOTE: PDF documents require the free Adobe Reader.

This page last updated on 05/08/2023

You are now leaving the NIH Clinical Center website.

This external link is provided for your convenience to offer additional information. The NIH Clinical Center is not responsible for the availability, content or accuracy of this external site.

The NIH Clinical Center does not endorse, authorize or guarantee the sponsors, information, products or services described or offered at this external site. You will be subject to the destination site’s privacy policy if you follow this link.

More information about the NIH Clinical Center Privacy and Disclaimer policy is available at https://www.cc.nih.gov/disclaimers.html