- Journal of Clinical and Translational Science
Introduction: With no approved treatments for COVID-19 initially available, the Food and Drug Administration utilized multiple preapproval pathways to provide access to investigational agents and/or medical devices: Expanded Access, Emergency Use Authorizations, and Clinical Trials.
- April 22, 2021
In an effort to make access to experimental agents easier and more efficient, Transforming Expanded Access to Maximize Support and Study (TEAMSS) has published new recommended guidelines, templates, and resources for physicians and institutions seeking Expanded Access for their patients.
- December 16, 2020
We hear much these days about the FDA’s decision to provide an Emergency Use Authorization for a COVID-19 vaccine. Emergency Use Authorization, or EUA, is a process by which the FDA authorizes an unapproved product to be used for serious or life-threatening conditions when there are no adequate, approved and available alternatives. This can only occur during a public health emergency. On 11 Dec
- The American journal of bioethics : AJOB
- July 14, 2020
Clara Dutari is bilingual, interpreting for Spanish-speaking patients at VCU Health. But she doesn’t just convert words, like a Spanish-English dictionary. She provides context, nuance and intuition to improve communication. One of six interpreters and translators at VCU Medical Center, Dutari sometimes sees patients nodding as their doctor speaks, but she can tell just by looking that the
- April 17, 2020
Infectious diseases physicians at Washington University School of Medicine in St. Louis have developed an expanded access program to give blood plasma from COVID-19 survivors to critically ill patients at Barnes-Jewish Hospital in St. Louis. Led by principal investigator Rachel Presti, MD, PhD, an associate professor of medicine, a team of researchers began enrolling potential donors last week
- Journal of clinical and translational science
Based on approval data, the U. S. Food and Drug Administration (FDA) program that allows for early access to drugs and medical devices before marketing approval, is a very effective means for seriously ill individuals to be treated with investigational agents. Currently the FDA receives, reviews, and approves >99% of over 1000 requests each year.