| CDER Patient-Focused Drug Development  FDA Issues Final Guidance on Patient-Focused Drug Development The U.S. Food and Drug Administration issued a final guidance "Patient-Focused Drug Development: Methods to Identify What is Important to Patients; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders." This guidance (Guidance 2) is the second in a series of guidance documents intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can more consistently inform medical product development and regulatory decision-making. The purpose of this guidance is to present a range of research methods and established best research practices that stakeholders might use to identify what is important to patients with respect to burden of disease, condition, or treatment, and the benefits and risks in the management of the patient's disease or condition. This guidance finalizes the draft guidance issued in October 2019. To view the final guidance, and for more information, please click here. | | | To contact FDA's CDER Patient-Focused Drug Development Program Staff, please email patientfocused@fda.hhs.gov. If this message was forwarded to you and you would like to subscribe to this free email subscription service, please visit our CDER PFDD Homepage and click the button "Subscribe to Email Updates" at the top of the page. | | | |
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