Steven Tjoe is an associate in the firm’s Technology and Life Sciences groups and a member of the firm’s FDA practice. He focuses his practice on product development strategies and regulatory compliance counseling, in particular as related to medical devices, digital health products, in vitro diagnostics, laboratory developed tests, compounded drugs, cell and gene therapies, and other drugs and biologics. Mr. Tjoe advises clients in analyzing premarket pathways, product adverse event risk profiles, product communications and marketing, and GMP compliance. Mr. Tjoe also advises on Hatch-Waxman patent listing and exclusivity issues, is a contributor to Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S, and regularly conducts risk analyses for offerings and transactions involving FDA-regulated entities across the medical device, drug, and biologic industries.
Recently, Mr. Tjoe has brought his experience as former regulatory counsel at FDA to help in vitro diagnostic, laboratory developed test, digital health developer, and non-traditional medical device manufacturer clients launching critical diagnostic and therapeutic products in response to the COVID-19 public health emergency maneuver FDA’s complex and evolving medical device and technology regulations and policies.
