Tag Archive: Biologics

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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Investigational Drug and Biologics Research

To request any of the templates below, please email our research navigators at ICTR_Navigators@jhmi.edu. FDA Formal Meeting Requests FDA Formal Meeting Request Guidance and Template FDA Formal Meeting Request Blank Template IND Exemption Request IND Exemption Request Guidance IND Application IND Application Guidance and Template for Drug Products IND Application Blank Template for Drug Products IND Application Guidance Template for Biologic (Somatic Cell Therapy) Products IND Application Blank Template for Biologic (Somatic Cell Therapy) Products Letters of Authorization/Right of Reference for INDs Letter of Authorization Guidance and Template for Drug Master Files Letter of Authorization Guidance and Template for Investigational … Continue reading

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

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, biologics devices and software in clinical research. The DDRS offers the following: Consultation Service This service includes a complimentary eight-hour consultation for those seeking help with managing the external (i.e. FDA) regulatory requirements of their research projects. For assistance, please submit an ICTR Connection Request . Read more.   Resources Information about complying with and managing the regulatory requirements for studies with investigational drugs, biologics, devices and software, are available outside … Continue reading