Tag Archive: DRUG AND DEVICE RESOURCES

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 … Continue reading

DDRS Consults–What to Expect


To initiate contact with the DDRS, investigators or team members must complete and submit a Connection Request. Submitting a Connection Request can be done by logging into the ICTR Connection Request website and selecting the DDRS service from the available options. All Connection Requests received will be reviewed by the Research Navigators in the order received in order to determine the basic nature of the request. Initial responses to Connection Requests can be expected within 5 to 7 working days, so please plan accordingly. Requests for general information requests will be answered directly by the Research Navigators wtihin 5 to 7 … Continue reading

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 a single IND or IDE application. If an investigator wishes to utilize the DDRS Consultation Service for more than one IND or IDE, he/she may do so. Each IND or IDE will be considered a separate ‘project’ and each will be provided an eight-hour consultation period free of charge. After the eight-hour consultation period has ended, additional regulatory support can be provided on a fee-for-service basis, for … Continue reading

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.

Drug and Device Resource Service (DDRS)


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 and devices in research.  The DDRS is comprised of an investigational drug, biologics, and device information repository (Resources) with a Project-Specific Consultation Service available for those who seek a higher level of assistance with management of the regulatory requirements of their research projects. *Please read the disclaimer. For assistance, please submit an ICTR Connection Request . To learn more about the consultation service and available resources, click the links below.