Steven Tjoe

Steven Tjoe is a partner in the firm’s Technology and Life Sciences groups and a
member of the firm’s Life Sciences Regulatory & Compliance practice. He focuses his
practice on product development strategies and FDA regulatory counseling, in particular
as related to medical devices, digital health products, in vitro diagnostics, laboratory
developed tests, compounded drugs, cell and gene therapies, biosimilars, and other
drugs and biologics. Steven advises clients in analyzing premarket pathways, product
adverse event risk profiles, product communications and marketing, and GMP
compliance. Steven also advises on 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.