David Rosen

Texas Court Vacates FDA's Laboratory Developed Test (LDT) Final Rule

Compounded GLP-1 Drugs: Texas Judge Denies PI Motion And Request For Stay Of FDA's Declaration That Tirzepatide Shortage Is Resolved; Plaintiff OFA Appeals

AI Drug Development: FDA Releases Draft Guidance

AI-Enabled Device Software Functions: FDA's Final Guidance For Predetermined Change Control Plans

GLP-1 Drugs: FDA "Re-Confirms" Decision Removing Tirzepatide From The Drug Shortage List

FDA Targets GLP-1 Providers With Warning Letters

Antibody Drug Conjugates Keep Growing: What You Need To Know

GLP-1 Drugs: Brand Companies Push FDA To Limit Compounding

GLP-1 Drugs: FDA Sued Over Removing Tirzepatide From The Drug Shortage List

GLP-1 Drugs: FDA Removes Lilly's Zepbound® And Mounjaro® (Tirzepatide Injection) From Its Drug Shortage List