FDA Issues Final Guidance on Patient Focused Drug Development - Drug Information Update

If your email program has trouble displaying this email, view it as a web page. 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 This guidance finalizes the draft guidance issued in October 2019. Learn More This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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