Regulatory Support (MIAP)

Do Your Patients Need Access to Investigational Drugs, Biologics, or Medical Devices Through FDA’s Expanded Access Pathway?

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.

MICHR Enables U-M Physicians to Request Remdesivir Through Expanded Access

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.

Working on a COVID-related drug or device project? Consult with MIAP

As the coronavirus pandemic began spreading to the U.S., the U-M research community responded with many innovative ideas to treat patients, prevent infections, and address shortages of medical products. MICHR’s MIAP, which supports investigator-initiated clinical trials with FDA submissions, became the first stop in the research project lifecycle for COVID-19 research ideas involving drugs or devices.