FDA Biomarkers

FDA Biomarker Qualification Program

Qualified biomarkers have the potential to provide valuable information that may reduce uncertainty in regulatory decisions during drug development. The Biomarker Qualification Program works with the requestor(s) in guiding biomarker development. Multiple interested parties often work together in working groups or consortia to develop a biomarker for qualification. This approach allows for shared resources, and reduces burden on individual collaborators. FDA has tasked our team to create a series of short videos to help explain biomarker and its qualification process.

Graphic Design USA 2017 American Web Design Award: Winner
2017 dotCOMM Awards: Honorable Mention
2017 Vega Digital Awards: Arcturus Award (Bronze)
2018 AVA Digital Awards: Platinum

U.S. Food and Drug Administration


Art Director: Simon Fong ▪ Illustrator: Freddy Trejo ▪ Animator/Editor: David Arbor

About FDA’s Biomarker Qualification Program

What Are Biomarkers And Why Are They Important?

What Do You Need to Consider When Qualifying a Biomarker?

Making Biomarker Development Successful

Simon Fong
Creative + Art Direction


Copyright 2018
Simon Fong