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Category results for: FDA Regulatory

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.  […]

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 […]

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 […]

The FDA Science Forum – May 26 and 27, 2021

SAVE THE DATE The 2021 FDA Science Forum Science as the Foundation for Protecting and Promoting Public Health Keynote Speaker: NIAID Director, Dr. Anthony Fauci The 2021 FDA Science Forum will be held virtually on Wednesday and Thursday, May 26 and 27, 2021. The Forum offers an exciting opportunity for the public to view the unique scientific […]

Searchable Database for Training Resources on FDA’s Updated CDER SBIA Learn Webpage

FDA’s CDER Small Business and Industry Assistance (SBIA) has revamped its CDER SBIA Learn webpage to include a comprehensive, searchable, easy-to-use database containing hundreds of training resources including recordings to webinars and conferences. This searchable database includes webinar and conference recordings from SBIA’s YouTube playlists from 2021, 2020, 2019 and 2018. SBIA also posts new conferences, webinars, and recordings on the SBIA LinkedIn page.

FDA-M-CERSI “Collaborating to Advance Health Equity for Diabetes and Chronic Kidney Disease” – February 10, 2021

FDA (OMHHE) and the University of Maryland-CERSI invite us to attend the Virtual Workshop Collaborating to Advance Health Equity for Diabetes and Chronic Kidney DiseaseDate: Wednesday, February 10, 2021 10:00 am – 3:00 pm ETThe workshop aims to advance attendees’ understanding of the following: Leveraging patient experience data and community/system approaches to inform care, drug development […]

FDA Adds 5 Regulatory Science Tools to Help Assess Medical Devices

The U.S. Food and Drug Administration (FDA) added 5 tools to the Catalog of Regulatory Science Tools to help assess medical devices. This catalog collates a variety of over 80 regulatory science tools developed by the Office of Science and Engineering Labs (OSEL) in the FDA’s Center for Devices and Radiological Health (CDRH). New tools […]

Pediatric Medical Devices 3-day Virtual Public Workshop – February 9-11, 2021

Through a cooperative agreement with the Critical Path Institute (C-Path), the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced a 3-day virtual public workshop, System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD) 2021 Virtual Workshop. The purpose of this workshop is to bring together stakeholders interested in pediatric […]

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