BARDA announces the 61st FDA Approval/Licensure/Clearance for Medical Countermeasures supported by BARDA under Novel Public Private Partnerships


WEB ANNOUNCEMENT
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Over the last 15 years since BARDA was established, our team of experts and scientists have collaborated with more than 300 industry partners to support development and manufacturing of a diverse portfolio of medical countermeasures needed to address national security and public health threats.

From investing in early innovation, to late stage development through U.S. Food and Drug Administration (FDA) approval, with each partnership, BARDA focuses on the end goal: ensuring products are available for the American people and the global community to protect health and save lives from a national security threat or other public health emergency. FDA approval, licensure, and clearance for medical countermeasures is a critical milestone for our partners and for BARDA and demonstrates the success of public-private partnerships in mitigating threats and creating a return on the public investment. That’s why we celebrate FDA approvals, licensures or clearances of medical countermeasures.

At BARDA, we are excited about the news of the recent FDA approval of a Burn Care Therapeutic, StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat) for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial thickness burns), from our partner Stratatech Corporation, a Mallinckrodt company. Designed with both dermal and epidermal layers composed of well-characterized human cells, StrataGraft is designed to deliver viable cells to support the body’s own ability to heal. BARDA and Stratatech partnered in 2015 to develop a new biological treatment pathway to improve healing outcomes in a mass casualty where burns are a medical consequence. The success of the program demonstrates an important advancement in the treatment of deep partial-thickness burns. Burn surgeons will now have a new biologic treatment to help eliminate or reduce the need for autografting.

  • StrataGraft is applied in appropriate aseptic conditions, such as the operating room, and can be sutured, stapled or secured with a tissue adhesive.
  • StrataGraft is cryopreserved in order to deliver viable cells upon application.
  • In the pivotal Phase 3 clinical trial, 96% of the StrataGraft treated areas across all adult participants did not require autografting.

From the development of the product in 2015 to the ultimate approval of StrataGraft in 2021, we are honored to be a part of this endeavor which may help make the world a healthier, safer place. For us, number approval #61 illustrates what government and industry can accomplish together. With novel medicines, diagnostics and vaccines we can save lives, protect the American people and enhance global health security.

Visit our FDA Approval Page to learn more about our support aiding our partners in achieving the other 60 approvals. While obtaining FDA approval is a major milestone and symbol of development success, regulatory approval is not the end game for those of us in public health preparedness and response. Making sure those products are available when they’re needed is the real end game. Each approval offers an opportunity to recognize the collective and collaborative work of the scientific community, government partners and our industry partners to enhance national health security. Approval number 61 highlights just that, 15 years of public and private partnerships to counter health security threats.

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...AND WE HAVE MORE IN THE PIPELINE

Explore BARDA's CBRN and COVID-19 medical countermeasure portfolio to learn about other exciting products in the pipeline.

Last Updated: June 16, 2021
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