Wednesday, January 10, 2024

Retirement of Tim Stenzel MD, Head of FDA Diagnostics

 According to several sources, Tim Stenzel MD has retired as head of diagnostics for the FDA, a position he took over in 2018.   The acting director will be Courtney Lias PhD, who has held a series of rising positions at the FDA since 2004.   Jeff Shuren MD JD (here) continues as head of the devices group as a whole, in his 14th year in that role.

Update Jan 29 2024:  Courtney Lias PhD is listed as Acting Director on Linked In. 

Stenzel's bio at Linked In is here.  He was chief operating officer at Invivoscribe 2014-2018, concurrent with the last years of his long professorship at Duke (1997-2018).

Courtney Lias's bio at Linked In is here.  She holds a PhD from Johns Hopkins (2003).  From 2003 to 2021, she was with the Division of Chemistry and Toxicology Devices, and from 2021 forward, head of gastrorenal, obgyn, and urology devices.  She was the FDA contact person for its effort to regulate IVDMIA devices (multiplex molecular assays) circa 2006 (here).  

Previous directors of the diagnostics group included Dr Steve Gutman (1992-2009) and Dr Alberto Gutierrez (2010-2017).