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FEDERAL REGISTER · NOTICEJuly 9, 2024

Request for Applications for New Members of the Clinical Trials Transformation Initiative/Food and Drug Administration Patient Engagement Collaborative

Document type
Notice
Agency
Health and Human Services Department
Published
July 9, 2024
Document number
2024-15008
ABSTRACT

The Food and Drug Administration (FDA or Agency), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is requesting applications from patient advocates interested in participating on the Patient Engagement Collaborative (PEC). The PEC is an ongoing, collaborative forum coordinated through the FDA's Patient Affairs Staff, Office of Clinical Policy and Programs (OCPP), Office of the Commissioner at FDA, and is hosted by CTTI. Through the PEC, the patient community and FDA staff are able to discuss an array of topics related to increasing meaningful patient engagement with diverse populations in medical product development and regulatory discussions at FDA. The activities of the PEC may include, but are not limited to, providing diverse perspectives on topics such as systematic patient engagement, transparency, and communication; providing considerations for implementing new strategies to enhance patient engagement at FDA; and proposing new models of collaboration in which patient, caregiver, and patient advocate perspectives can inform medical product development and regulatory discussions.

Abstract as published in the Federal Register.

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.