Category Archive: Child of DDRS

Drug and Device Resources


The information resources compiled at the various links below are available for use by all investigators and project teams at no cost. Through these documents, the Research Navigators 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. **EFFECTIVE IMMEDIATELY** CBER’S new 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 […]

DDRS Consultation Service


The Project Specific Consultation Service includes a complimentary eight-hour consultation. Additional regulatory support beyond the eight hours can be obtained at an hourly rate of $72.00. What Is a “Project”? A project is defined as: At the preclinical stage (i.e. pre-IND or –IDE), a single investigational entity that may be composed of multiple components (i.e. drug and/or biologic and/or device) which are all required to achieve the desired effect. The investigational entity that is identified in a single IND or IDE application. An eight-hour consultation period is available free of charge for each project, as defined above. At the conclusion […]

Drug and Device Resources Disclaimer


The regulatory guidances, templates, and other materials provided at this site are available to the public and are 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.