Lauren Sager

FDA Makes Good On Promise To Publish CRLs For Unapproved Drugs And Biologics

FDA Finalizes Guidance On Predetermined Change Control Plans For AI-Enabled Medical Device Software

FDA "PreCheck"? FDA Issues Draft Guidance On Predetermined Change Control Plans For Medical Devices

FDA Takes Next Step In Advancing Diversity In Clinical Studies

2021 Enforcement Review: FDA-Regulated Medical Products