Stacey Borenstein

Company: US Food & Drug Administration (FDA)

Job title: Biologist

Seminars:

Regulatory Considerations for Gene Therapy-Specific Companion Diagnostic Devices 2:15 pm

FDA oversight of in vitro diagnostic devices, including companion diagnostics (CDx) Importance of Co-development of a CDx and planning for contemporaneous approval Overcoming challenges associated with CDx developmentRead more

day: Day 2 REGULATORY PM