Food and Drug Administration (FDA) Activities
This section describes basic and clinical research activities supported or sponsored by the Federal government.
Food and Drug Administration (FDA)
The FDA and the American Society of Nephrology (ASN) co-founded the Kidney Health Initiative (KHI), a public-private partnership, in 2012. The mission of KHI is to advance scientific understanding of the kidney health and patient safety implications of new and existing medical products and to foster development of therapies for diseases that affect the kidney by creating a collaborative environment in which FDA and the greater nephrology community can interact to optimize evaluation of drugs, devices, biologics, and food products. Details regarding mission and organizational structure of KHI may be found on the KHI website. Member organizations include patient organizations, professional organizations, regulated industry (including both pharmaceutical and device companies), dialysis providers, academic research organizations, contract research organizations, research institutes, and other government agencies. Voting activities of the Board of Directors includes the endorsement of projects proposed by the membership.
Criteria for project endorsement are:
- Adherence to KHI mission
- Impact potential
KHI projects rely on the participation and sweat equity of KHI members to produce the project deliverables, however membership is not a requirement for participation in KHI workgroups. Since its inception in 2012, the founding partners (FDA and ASN) conceived of the three pilot projects undertaken immediately by KHI. One project is designed to address the paucity of data that exist to guide the drug dosing of critically ill patients with acute kidney injury receiving continuous renal replacement therapies (CRRT). Another project is designed to elucidate appropriate endpoints for lupus nephritis trials. A final pilot project already underway is a white paper intended to identify barriers to innovation in the kidney health space. The intent is that the white paper may serve as a roadmap for future KHI projects that will be generated by the KHI members. While participation in KHI workgroups is not restricted to KHI members, KHI holds annual stakeholders meetings for its members where proposed projects ideas are discussed and developed. KHI members are also able to submit project proposals through the KHI website. The annual membership fees vary depending on the size and type of organization, ranging from $30,000/year to free.
Patrick Archdeacon, MD
Medical Officer, Center for Drug Evaluation and Research
This information was reviewed by KICC agency representatives. It may not reflect new or future agency activities. For more information, please contact the listed representatives.