Division of Clinical Research

Office of the Vice President and Innovation

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FDA will now regulate some drugs as devices

Summary: Following a recent court case, Genus Med. Techs., LLC v. FDA, it was determined that the FDA cannot classify products that meet the definition of devices as drugs as they have previously been doing with some imaging agents.  As a result the FDA will transition specific products being regulated as drugs to being regulated as devices.  […]

Financial Interest Report (FIR) annual update opens on Monday, May 10th.

All COI investigators with active research studies at VCU must complete their annual update on or after May 10th. The annual update must be completed regardless of whether they have recently updated their FIR prior to May 10th or if they have no changes to make. All individuals with a FIR in the AIRS will get an […]

FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19

April 14, 2021 During this worldwide public health emergency, the FDA has used a variety of tools to oversee facilities that manufacture FDA-regulated products. These tools include record requests in advance of or in lieu of a drug facility inspection, relying on information from trusted regulatory partners, and remote interactive evaluations (such as remote livestreaming […]

Call for Pilot Project Applications in Drug Abuse Research

The Central Virginia Center on Drug Abuse Research (P30DA033934) seeks 1 year pilot grant proposals for the following two goals: 1) To provide resources supporting new ideas and initiatives, which have high potential to generate data important for applying for federal funding in the field of drug abuse research; and 2) To supply funds for […]

Call for Undergraduate Research Assistant Positions for spring and summer 2021

Research teams are invited to submit position postings for research assistants via the VCU Student Opportunity Center (SOC).   SOC allows you to more effectively share your research opportunity with aspiring undergraduate researchers while streamlining the recruitment and application review process on your behalf.  It also helps us identify the contributions you are making to experiential […]

Cures Within Reach funding opportunity

Cures Within Reach funding opportunity Request for Proposals (RFP) for clinical repurposing trials in any rare pediatric disease. Submissions are due by March 17 for up to $50,000 in funding. More info at https://bit.ly/cwrrfps: Projects repurposing approved drugs, devices, nutraceuticals and/or diagnostics in any rare pediatric disease are eligible Proof of concept clinical trials are preferred; with the potential to co-fund […]

FDA Adds 7 Regulatory Science Tools to Help Assess Medical Devices

The U.S. Food and Drug Administration (FDA) recently added 7 tools to the Catalog of Regulatory Science Tools to help assess medical devices, including phantoms, laboratory methods, and models: Approach to validate simulation-based distributions: Application to focused ultrasound Electrophysiological biomarkers of brain injury High electric-field generator for MRI safety testing Microcalcification templates o2S2PARC: Open online […]

Health Equity and COVID-19 Webinar – 2/25 at 6:00 p.m. EST

Join the FDA’s Office of Minority Health and Health Equity on February 25 from 6:00 p.m. – 7:00 p.m. EST for a conversation about health equity and COVID-19 with Dr. Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research, and RADM Richardae Araojo, Director of FDA’s Office of Minority Health and Health Equity. Learn about […]

Recently Posted FDA Guidance Document: COVID-19 Convalescent Plasma

Investigational COVID-19 Convalescent Plasma: Guidance for Industry On August 23, 2020, FDA issued an Emergency Use Authorization (EUA)  for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19.  FDA has subsequently reissued this EUA with revisions.   FDA recognizes that while COVID-19 convalescent plasma may be used under an EUA consistent with the […]

Graphic Medicine at VCU Libraries

Thurs., Feb. 11 at 10:30 a.m. Led by Cindy Jackson and Talicia Tarver “Graphic medicine” is a term coined by Ian Williams, MD, to indicate the “intersection of the medium of comics and the discourse of healthcare.” Through graphic medicine, practitioners, patients and scholars have a medium through which they can discuss complex health topics using the type […]

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