The Drug and Device Resource Service (DDRS) provides Johns Hopkins University investigators and project teams access to resources needed to help manage the development and use of investigational drugs, biologics devices and software in clinical research.
Information about complying with and managing the regulatory requirements for studies with investigational drugs, biologics, devices and software, are available outside of the DDRS Consultation Service, by submitting an ICTR service request. We can provide answers to general regulatory questions as well as access to a list of Frequently Asked Questions, templates, and other guidance documents. The list of informational resources will continue to grow as the DDRS develops.
CBER’S Current Mailing Address
U.S. Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
W071, G112
Silver Spring, MD 20993-0002
Please disregard any other address for CBER in any of our posted documents.
Disclaimer
The regulatory information sheets, templates, and other materials provided at this site are available for researchers to use with appropriate acknowledgement of source material. All material provided on this site is for informational purposes only. The Johns Hopkins Institute for Clinical and Translational Research makes no representations as to the accuracy, completeness, correctness, suitability, or validity of any information on this site and will not be liable for any errors, omissions, or delays in this information or any losses, injuries, or damages arising from its display or use.
