Do your patients need access to investigational drugs, biologics or medical devices through FDA’s Expanded Access pathway?

April 27, 2021  //  FOUND IN: Updates & Resources

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.

Resources are available for every step of the Expanded Access process, from determining patient eligibility and seeking FDA and IRB approval, to contracts, submissions and reporting responsibilities.

Expanded Access resources include: 

  • Cover letter, authorization and annual report templates
  • Sample application for single-patient IND (investigational new drug) submissions
  • Understanding the responsibilities of the sponsor and investigator
  • Submitting the request to the appropriate FDA division
  • Documentation and tracking

Additional materials, such as advice for agent handling, treatment and patient communication, as well as additional training resources, will be added to the site in the coming months. Access the materials here.

“Obtaining approval for an experimental therapeutic for patient use can be an arduous and complex process,” explained George Mashour, M.D., Ph.D., codirector of MICHR, chair of anesthesiology, and co-PI on TEAMSS. “TEAMSS is here to simplify and streamline the process across our CTSA consortium.”

TEAMSS continues to evaluate and assess national resources and infrastructure for Expanded Access. For more information, please contact TEAMSS through the web form or teamss@clic-ctsa.org. If you are interested in sharing your thoughts and experiences with Expanded Access requests, please contact TEAMSS.

What is TEAMSS? 

TEAMSS (Transforming Expanded Access to Maximize Support and Study) seeks to advance clinical care and translational research by improving patient access to experimental drugs, biologics and medical devices. This federated, national consortium for Expanded Access interventions is led by U-M in partnership with Duke University, the University of Rochester, and the University of Texas Southwestern. Expanded Access provides an opportunity for patients who either lack therapeutic options or who are ineligible for clinical trials to potentially benefit from the clinical use of experimental drugs, biologics and medical devices.

By developing this national consortium, TEAMSS will build a positive impact by, for the first time, creating a foundation for an integrated, nationwide approach to Expanded Access that can improve care for the most vulnerable patients. TEAMSS is funded by the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health.

Website: https://michr.umich.edu/news/2021/4/19/do-your-patients-need-access-to-investigational-drugs-biologics-or-medical-devices-though-fdas-expanded-access-pathway

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