The Kidney Health Initiative Welcomes New FDA Commissioner

By Zach Cahill

January 9, 2020

KHI_Logo-Horizontal-Color_1.jpgThe Kidney Health Initiative (KHI) sent a congratulatory letter to Stephen Hahn, MD, on his recent confirmation as Commissioner of the US Food and Drug Administration (FDA).

KHI is the American Society of Nephrology (ASN)’s public-private partnership with the FDA. Founded in 2012, KHI now has more than 100 member organizations and is the largest consortia in the kidney community. Raymond C. Harris, MD, FASN, the ASN Co-Chair for KHI, said in a statement:

“The US Food and Drug Administration has a significant impact on the lives of the 37 million Americans with kidney diseases. The Kidney Health Initiative congratulates Stephen Hahn on his confirmation as Commissioner and looks forward to working with him to catalyze innovation and the development of safe and effective patient-centered therapies for people living with kidney diseases.”ucm519143.png

The FDA plays a critical role in bringing innovative treatment options to people with kidney diseases. KHI has collaborated with dozens of FDA staff members across acrost the agency, including the Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Biologics Evaluation and Research, over the years on a variety of pre-competitive projects aimed at reducing barriers to innovation in the kidney community.

KHI recently deepened its relationship with the FDA through two new projects inspired by the Advancing American Kidney Health initiative. The first is a contract with the FDA for a project titled “Building Capacity to Incorporate Patient Preferences into the Development of Innovative Alternatives to Renal Replacement Therapy (RRT)” that will develop a patient preference survey for novel RRT products. The second project titled “Clinical Trial Design to Support Innovative Approaches to Renal Replacement Therapy” was initiated at the request of the FDA and will provide uniform definitions and recommend trial designs for future RRT products.

For more information about KHI, see khi.asn-online.org.

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Zach Cahill
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KHI_Logo-Horizontal-Color_1.jpgThe Kidney Health Initiative (KHI) sent a congratulatory letter to Stephen Hahn, MD, on his recent confirmation as Commissioner of the US Food and Drug Administration (FDA).

KHI is the American Society of Nephrology (ASN)’s public-private partnership with the FDA. Founded in 2012, KHI now has more than 100 member organizations and is the largest consortia in the kidney community. Raymond C. Harris, MD, FASN, the ASN Co-Chair for KHI, said in a statement:

“The US Food and Drug Administration has a significant impact on the lives of the 37 million Americans with kidney diseases. The Kidney Health Initiative congratulates Stephen Hahn on his confirmation as Commissioner and looks forward to working with him to catalyze innovation and the development of safe and effective patient-centered therapies for people living with kidney diseases.”ucm519143.png

The FDA plays a critical role in bringing innovative treatment options to people with kidney diseases. KHI has collaborated with dozens of FDA staff members across acrost the agency, including the Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Biologics Evaluation and Research, over the years on a variety of pre-competitive projects aimed at reducing barriers to innovation in the kidney community.

KHI recently deepened its relationship with the FDA through two new projects inspired by the Advancing American Kidney Health initiative. The first is a contract with the FDA for a project titled “Building Capacity to Incorporate Patient Preferences into the Development of Innovative Alternatives to Renal Replacement Therapy (RRT)” that will develop a patient preference survey for novel RRT products. The second project titled “Clinical Trial Design to Support Innovative Approaches to Renal Replacement Therapy” was initiated at the request of the FDA and will provide uniform definitions and recommend trial designs for future RRT products.

For more information about KHI, see khi.asn-online.org.

Date:
Thursday, January 9, 2020