FDA Issues Final Guidance on Patient Focused Drug Development

The purpose of this guidance is to present a range of research methods and established best research practices that stakeholders might use t

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . FDA Issues Final Guidance on Patient Focused Drug Development   Today 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 This guidance finalizes the draft guidance issued in October 2019.   The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2021 Recordings on YouTube Follow on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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