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iCAN is a proud partner of the FDA
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iCAN is a proud partner of the U.S. Food and Drug Administration (FDA) and is pleased to share its important resources for kids and families. The FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. iCAN is proud to be a part of the FDA's CDRH Patient and Caregiver Connection and Total Product Life Cycle (TPLC) Advisory Program (TAP), which provides patients and caregivers with an opportunity to share their experiences living with a condition

or using medical devices.

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What is FDA's Patient and Caregiver Connection?

The Patient and Caregiver Connection is a partnership that provides CDRH staff with broad and timely access to patient and caregiver experiences. Partner organizations will collect feedback about specific issues from their members and share that feedback with CDRH. This patient feedback on the impact of the medical condition on individual patients can help provide a rich context for regulatory decision-making.

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What is the TAP program?

The Total Product Life Cycle Advisory Program (TAP) is a voluntary pilot program launched by the FDA’s Center for Devices and Radiological Health (CDRH) in October 2023. The TAP Pilot is one of the commitments between the FDA and industry as part of the MDUFA V reauthorization, which aims to provide faster patient access to safe and effective medical devices, increase innovation, improve patient safety through enhanced surveillance and data collection, and provide a more efficient regulatory process for FDA and industry.  

Making a Real, Lasting Impact

September 15, 2025: iCAN Youth Members, Anvita, Inaaya, and Meghan, along with iCAN President, Leanne West, shared their stories and insights at the FDA's Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children's Act (BPCA) and Pediatric Research Equity Act (PREA).

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Young Professional Network's Open Letter to the FDA

September 15, 2025: Submitted as an written comment to the FDA, this letter is crafted with members of iCAN's Young Professional Network (YPN). Born from the closure of multiple pharmaceutical companies' Pediatric Centers of Excellence, the open letter addresses the need for continued engagement with pediatric patients, patient organizations, and young people. 

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​“...By partnering with pharmaceutical companies to host direct engagements with pediatric patients and caregivers, iCAN provides a platform for these companies to directly hear from young people and to truly understand the challenges they face…”

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Parent and Patient Perspectives Take Charge!

September 2024: The purpose of the workshop was to solicit input from stakeholders on increasing the enrollment of historically underrepresented population in pediatric clinical studies, and to encourage pediatric clinical study participation that reflects the prevalence of the other disease or condition among demographic subgroups, where appropriate and other topics. Michael and Michelle Burgess, KIDS Illinois, gave the Keynote Address!

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iCAN x FDA Videos

ADEPT 9:Enhancing Diversity in Therapeutics Development for Pediatric Patients (Welcome & Intro, S1)
Dr. Bocell for FDA Keynote Presentation by Tracy Gray
Annie Saha for the FDA Keynote at iCAN 2021 Summit
Keynote Presentation by Tracy Gray from CRDH at the FDA for the 2021 iCAN Summit
Freda Lewis-Hall 2016 Summit Welcome
My Experience at the FDA by Rhiannon for the 2020 iCAN Summit
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