Tag Archive: Drug and Device Resources

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. Clinical Research Billing Compliance (CRBC) ClinicalTrials.gov Program Office of Human Subjects Research (OHSR) & Johns Hopkins Medicine Institutional Review Boards (IRB) Research Ethics Consultation Clinical Research Support Services (CRSS) Drug and Device Resource Service (DDRS) Office of Research Administration (ORA) Research Participant Advocacy Program

Drug Discovery Development Core

A collaboration between Johns Hopkins University and the University of Maryland. 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 Library maintains, distributes, and screens drug library (FDA approved) compounds. This library … Continue reading

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Drugs, Biologics, Vaccines and Devices

The Drugs, Biologics, Vaccines, and Devices community is lead by 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 … Continue reading

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 … Continue reading

Investigational Botanical Drug Products

To request this template, 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. 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 … 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 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 … 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.