PURPOSE: The U.S. Food and Drug Administration's CDER’s Professional Affairs and Stakeholder Engagement (PASE) provides a focal point for advocacy, enhances two-way communication and collaboration with healthcare professionals, patients, patient groups, and others concerning drug development, drug review, and drug safety.  Workshop participants will become familiar with PASE coordinated efforts to make significant improvements in the safe use of medications and communication with clinicians and projects aimed to address patient outcomes and prescribing behavior.  Three representative activities including a post hip and knee surgery opioid outcomes study, a qualitative focus group to better understand how physicians access FDA regulatory information and a nationwide standardization of intravenous and oral liquid medications will be presented. DESCRIPTION: Participants will obtain an overview of recent developments at FDA PASE related to patient and health care professional engagement, funded outcomes research and use of prescriber qualitative data to help inform decision making & influence prescribing behavior. The workshop will cover a) an overview of FDA/CDER’s efforts to manage and coordinate preventable harm and/or safe medication use projects with federal and state partners as well as private sector stakeholders, b) detailed examples of FDA funded original outcomes research: Kaiser opioid outcomes study and the ASHP national standardization study, and c) feedback from physicians regarding their ability to access and understand of FDA’s public health messaging pertaining to drugs. During the workshop, participants will be asked to share their perspectives regarding future priorities for FDA/CDER’s efforts to promote outcomes research related to preventable medication harm as well as efforts to enhance dissemination and uptake of findings into practice.   This interactive and informative workshop will be valuable to researchers, clinicians, and industry analysts who are interested in the measurement and management of efforts to reduce preventable medication harm as well as communication strategies.