TEAMSS (Transforming Expanded Access to Maximize Support and Study) seeks to advance clinical care and translational research by improving patient access to experimental therapies. This federated, national consortium for Expanded Access interventions is a partnership led by the University of Michigan with Duke University, University of Rochester and University of Texas Southwestern
- August 25, 2022On Thursday, 4 August 2022, a public health emergency was declared for the contagious disease known as monkeypox. Do you know how to access tecovirimat (brand name TPOXX® from Siga Techologies) an anti-viral to treat patients that have tested positive for monkeypox? Several players are involved in making this happen! TPOXX® is approved for the treatment of human smallpox which is caused by the
- 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
- June 05, 2020
Since MICHR was awarded the Transforming Expanded Access to Maximize Support and Study (TEAMSS) grant two years ago, the consortium of universities involved in TEAMSS has worked to develop and test infrastructure, best practices, and reduce burdensome data collection for expanded access that will allow other academic medical centers to become more effective and efficient in supporting these requests.
- 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.