TEAMSS

How often is Expanded Access used, and how often is support for it available? This is what the TEAMSS (Transforming Expanded Access to Maximize Support and Study) collaborative set out to determine through a survey of academic medical centers through the CTSA (Clinical and Translational Science Awards) network. Forty-seven sites responded, and the findings have now been published in the Journal of

On 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

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.

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

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.