Scott Winiecki

Lead Medical Officer at CDER/Food and Drug Administration

Speaker

Dr. Scott K. Winiecki received his MD degree from the University of Maryland and completed his pediatric training at the Children’s Hospital of Philadelphia. After 12 years in private pediatric practice, he joined the U.S. Food and Drug Administration in 2011. While working on the safety of blood products and vaccines, he received the FDA’s “Outstanding New Reviewer” Award and a Public Health Achievement Award. After 5 ½ years working on biologics, he joined the Center for Drugs in 2016. He spent 6 years managing the Safe Use Initiative, a group whose goal is to reduce preventable harm from medications. In December 2022, he joined the Rare Disease Team where he works collaboratively with external and internal rare disease stakeholders to drive scientific and regulatory innovation and engagement to accelerate the availability of treatments for patients with rare diseases