Regulatory Affairs

Office of the Vice President and Innovation

Category results for: FDA Regulatory

Oct. 21: Webinar – Humanitarian Device Exemption Program

Date: October 21, 2019 Time: 12:00 PM EDT-01:30 PM EDT Registration is not necessary. On Monday, October 21, 2019, the FDA will host a webinar for device manufacturers and industry to discuss and answer questions about the Humanitarian Device Exemption Program Final Guidance published on September 5, 2019 This final guidance describes how the FDA determines whether […]

Recently Posted FDA Guidance Documents

9/6/2019 – Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff FDA developed this guidance document to provide clarity to industry and FDA staff about the current review practices for the Humanitarian Device Exemption (HDE) Program. This programmatic guidance addresses commonly asked questions about HDEs and Humanitarian Use Devices (HUDs), including FDA actions […]

Recently Posted FDA Guidance Documents

The Center for Devices and Radiological Health (CDRH) posted these new items on on August 29, 2019. To view listings for other dates, see CDRH New – News and Updates. Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions This guidance document describes the Food and […]

Regulatory Education for Industry (REdI): Clinical Investigator Training Course

November 12-14, 2019 The Hotel at the University of Maryland, College Park, MD The course fee is $500 and includes attendance to program sessions, coursebook with all speaker slides, breakfast on November 12-14, and daily refreshment breaks. A room block is available for the rate of $179/night This course provides a study of clinical trial […]

Using DNA/RNA as Drugs: From Discovery to Development

Monday, September 9th, 12:00 to 1:00pm Main Hospital – Learning Center (Main Hospital, first floor, across from the cafeteria), MCV Campus Please join us for the Wright Center for Clinical and Translational Research’s Discovery Dialogues seminar, “Using DNA/RNA as Drugs: From Discovery to Development,” presented by Wright Center Clinical Research KL2 Scholar Guizhi (Julian) Zhu, Ph.D. Faculty, staff, students, patients, and families […]

September’s Journey to Impact presentations from the “Beyond the Bench” Workshop Series

Journey to Impact: Dr. Horn-Ranney Fri. September 6th, 12:00 – 1:00 PM Main Hospital – M2 – Room 2-125 Hear from Dr. Horn-Ranney (CEO of Tympanogen) about founding her medical device company, navigating the transition from academia, and the importance of research commercialization Journey to Impact: Dr. Eric Edwards Fri. September 20th, 12:00 – 1:00 PM Main […]

Recently Posted FDA Guidance Documents

8/7/2019 – Fabry Disease: Developing Drugs for Treatment Guidance for Industry [DRAFT] Issued by: Center for Drug Evaluation and Research The purpose of this guidance is to provide recommendations to sponsors regarding clinical trial design features that can support the approval of drugs and biological products intended for the treatment of Fabry disease (FD). 7/31/2019 […]

Sept. 11-12: FDA 2019 Science Forum

Transforming Health: Innovation in FDA Science Dates: September 11-12, 2019 Location: Silver Spring, MD (and webcast) Forum Topic Areas include: Precision Health: Research exploring topics that may enable precision health for individuals and special populations such as sex differences, the microbiome, personalized modeling, genetics, computational modeling, and in vitro/in vivo assessment of an individual’s […]

Updated Resource for Investigators and Sponsors of Investigational Drugs at VCU

The VCU Health Investigational Drug Service has updated their website with new guidance and policies for research teams as well as for sponsors/monitors. Please visit their page for more information:

New Navigational Resource

Find resources for your research more easily and get help finding what you need, when you need it. The Wright Center Research Navigation Page is available to connect researchers to the resources they need to conduct their research. The Wright Center assists researchers at all stages of the process and at any point in their […]

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