DSCSA Compliance, Stabilization Period, And Guidance
Get important information regarding Drug Supply Chain Security Act (DSCSA) implementation, including:
- Overview of where DSCSA is in the implementation journey from a statutory perspective
- FDA expectations during stabilization period
- Recent guidance from FDA to assist the industry in DSCSA implementation
Read more on pharmaceutical traceability and DSCSA implementation here.
Presenter
Connie T. Jung, PhD, RPh
Senior Advisor for Policy
U.S. Food & Drug Administration
Center for Drug Evaluation & Research (CDER)
Office of Compliance / Office of Drug Security, Integrity & Response
Dr. Jung is currently Senior Advisor for Policy in the Office of Drug Security, Integrity, and Response (ODSIR) in FDA’s Center for Drug Evaluation and Research, Office of Compliance. Her work focuses on development of policy and regulatory strategies to improve the security and integrity of the U.S. drug supply to protect patients from counterfeit or stolen product. She received her B.S. in Pharmacy from The Ohio State University and her Ph.D. in Pharmaceutical Sciences from the University of Cincinnati.
Dr. Jung joined the FDA in 1999 as a toxicology researcher in the Center for Food Safety and Applied Nutrition, and later served as a Regulatory Reviewer of bioequivalence studies in the Office of Generic Drug before working on supply chain issues.