Patient input is a critical part of CBER’s understanding of diseases and conditions. Engaging with patients and caregivers, and listening to their perspectives on their diseases and treatments, may help us advance patient-focused medical product development. CBER’s patient engagement program is committed to incorporating patient involvement in the center’s regulatory work in accordance with relevant provisions in the 21st Century Cures Act of 2016 and the Food and Drug Omnibus Reform Act of 2022 (FDORA), as well as in commitments under PDUFA VI, authorized under the Food and Drug Administration Re-authorization Act (FDARA) in 2017, and PDUFA VII, authorized in part by the FDA User Fee Reauthorization Act of 2022.
Furthermore, FDA offers the patient community a web platform, Patients Ask FDA, which is designed to encourage patients, caregivers, patient groups, patient advocates, and health care professionals to ask a question, request a meeting, or request a Patient Listening Session for all the FDA medical product Centers (biologics, drugs, and devices), and provide effective and efficient responses. Note: This webform is not for industry stakeholders.
Learn about FDA’s Patient Engagement activities and resources at: https://www.fda.gov/patients/learn-about-fda-patient-engagement.
