Tag Archive: Drug and Device Resources

Lab Resources


The ICTR laboratories provide coordinated help across several related programs, all focused on the foundational components required to effectively translate new drugs, biologics, vaccines, devices, biomarkers and diagnostics into clinical trials and eventually clinical practice. Biologics Translational Program This lab offers: Biologic product development and testing Consultative support for biologic development Preclinical testing to clinical production for early phase clinical testing Good Manufacturing Practices (GMP) facility and expertise to produce and maintain (stability testing Cell lines Gene vectors Antibodies Peptides Contact: Vic Lemas, PhD Lab Leader 410-614-5411 | mvlemas@jhmi.edu Ruth Karron, MD Lab Leader 410-614-0319 | rkarron1@jhmi.edu Submit a Connection […]

Regulatory 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. ClinicalTrials.gov Program Because all clinical trials funded in whole or in part by the National Institutes of Health (NIH) are required to be registered and reported, we provide investigators with instructions to stay in compliance through our ClinicalTrials.gov program. Read more. Drug and Device Resource Service (DDRS) DDRS provides tools needed to help manage the development and use of investigational drugs and devices in research. The service is available for […]

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 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 […]

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.