Tag Archive: Drug and Device Resources

Drug Discovery Development Core


“A collaboration between Johns Hopkins University and University of Maryland” Contacts Barbara Slusher Co-Director bslusher@jhmi.edu James Polli Co-Director jpolli@rx.umaryland.edu Craig Hendrix Co-Director chendrix@jhmi.edu Discovery & Early Development Medicinal Chemistry Unit: Reference compound synthesis to synthesize commercially unavailable compounds of key biological and pharmacological interest to core users as reference and/or tool compounds. Contact: Takashi Tsukamoto, PhD., 443-629-7984, ttsukamoto@jhmi.edu David Meyers, PhD., 410-502-4804, dmeyers7@jhmi.edu Assay Development and Screening Unit: Biochemical and assay development support will assist biochemical assays development for putative therapeutic targets along with Cell-based assay development support that will facilitate development of cell-based drug screening assays. The Drug Screening […]

Regulatory & Ethics Support


The ICTR offers education, expert advice and resources to better equip study teams to conduct research that is ethical, relevant and responsive to the interests of patients and research participants.

Service Request: Drug and Device Resource Service (DDRS) Consultation


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 […]

Drugs, Biologics, Vaccines and Devices


The Drugs, Biologics, Vaccines, and Devices community is lead by co-leaders Barbara Slusher and Clifford Weiss. The mission of the Drugs/Vaccines/Biologics/Devices Translational Research Community (TRC) is to stimulate highly innovative researchers and research programs that translate laboratory findings into new drug, device, or biologic therapeutics for human disease. We have been working to establish a vibrant and collaborative translational community for scientists across the Johns Hopkins Schools of Medicine, Public Health, Nursing, Engineering, and Arts and Sciences who are conducting research in these areas. The goals of the Drugs/Vaccines/Biologics/Devices TRC are to: Identify, support and enhance institutional capacity within the […]

Combination Products


Definition Combination products are defined in 21 CFR 3.2(e). The term combination product includes: A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity; Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products; A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved […]

Investigational Botanical Drug Products


To request any of the templates below, please email our research navigators at ICTR_Navigators@jhmi.edu. IND Application IND Application Guidance and Template for Lawfully Marketed Botanical Products with No Known Safety Concerns IND Application Guidance and Template for Unmarketed Botanical Products and Botanical Products with Known Safety Concerns

Investigational Device Research


To request any of the templates below, please email our research navigators at ICTR_Navigators@jhmi.edu. IDE Application IDE Application Guidance and Template for Significant Risk Devices IDE Application Blank Template for Significant Risk Devices eCopy Instructional Checklist eCopy Instructional Checklist Letters of Authorization for 510(k) or PMA Guidance and Template for Letters of Authorization to 510(k) or PMA Protocol Development Resources Protocol Development Guidance for Clinical Investigations Using Investigational Devices Device Study Reporting Requirements NSR Device Reporting Requirements SR Device Reporting Requirements IDE Study Forms Device Accountability Log Inquiries and Requests for Support Please submit an ICTR Connection Request.

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 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 […]

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.