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Drug Delivery Partnerships
September 21-24, 2020
Proudly part of BioPharm AmericaDelivered Digitally | US Eastern Daylight Time

Lana Shiu, MD
Executive Director, Medical Device Regulatory Affairs, Global Regulatory Affairs and Safety at Amgen


Dr. Lana Shiu is currently Amgen’s Head of Medical Device Regulatory Affairs. She spent over 12 years at FDA and was previously at FDA CDRH Office of Device Evaluation to lead combination product device reviews after spending 3 years as the Senior Medical Advisor at Office of Combination Products. She started out her career as an engineering reviewer for FDA after graduating from Vanderbilt University with engineering degree in Electrical Engineering and Biomedical Engineering. She left FDA in 1994 to go to medical school on a Navy scholarship and later graduated from George Washington University School of Medicine with her M.D. After serving her time with the Marines and Navy Construction Battalions, Lana finished her Internal Medicine Residency at Emory University to become board-certified in Internal Medicine before returning to FDA.

Agenda Sessions

  • USP 800 - How it will Affect Drug Delivery and Formulations