Resource Center

https://aakp.org/

• Diana Clynes, Executive Director
• Erin Khale, Director of Operations
• Richard Knight, MBA, President
• Paul Conway, Past President, Chair of Public Policy and Global Affairs

https://www.kidneyfund.org/

• Deborah Darcy, Director of Government Affairs
• Michael Ly, Director of Public Policy

https://homedialyzorsunited.org/

• Denise Eilers, BSN, RN, Board Member
• Nieltje Gedney, Treasurer
• Nichole Jefferson, President

https://igan.org/

• Bonnie Schneider, Founder

https://www.kidney.org/

• Andrew Fullerton, Government Affairs Manager

https://nephcure.org/

https://ohf.org/

• Kim Hollander, Executive Director

https://pkdcure.org/

• Alexis Denny, Director of Government Affairs

Center for Devices and Radiological Health (CDRH) Learn

An educational tool with learning modules describing regulations for medical device and radiation emitting products

Center for Biologics Evaluation and Research (CBER) Advanced Technologies Team (CATT)

An overview of the CATT program purpose and scope, and a description of the process for interaction

FDA Breakthrough Devices Program

FAQs related to the FDA breakthrough program including core benefits, eligibility, and guidance

FDA Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) Forum

An overview of the purpose and process for INTERACT meetings, which are informal non-binding consultations with the CBER at FDA

Kidney Health Initiative (KHI) Guide to Regulatory Resources for the Product Developer [PDF]

A resource guide to increase the awareness and understanding of FDA Centers and the products they review; communication mechanisms that enable developers to obtain advice from the FDA; and available programs intended to facilitate development and review of eligible renal replacement therapy products

KHI Clinical Trial Design Resources

A series of resources on clinical trial design in the context of kidney health

Kidney Health Initiative (KHI) Patient Focused Development

Aggregated resources and research to support patient focused development

KHI Patient Preferences for Device Development

Primary research and information to help incorporate patient preferences in device development

National Kidney Foundation (NKF) Patient and Family Resources

Patient-centric resources to understand and navigate kidney care

Patient-Centered Outcomes Research Institute (PCORI)

Actionable information and tools to support patient engagement in research

A Four-Phase Model of Transdisciplinary Team-Based Research: Goals, Team Processes, and Strategies

An article from Translational Behavioral Medicine on the burgeoning interest and investments in cross-disciplinary team-based research, and particularly in transdisciplinary (TD) team-based research

NIH Research Portfolio Online Reporting Tools (RePORT)

Database of all NIH grants to search for both active and past projects