Baker Hostetler attorney Winston Kirton says life sciences companies that are active in both the U.S. and the EU need to change their view of supply c...
A Clinical Trial Vanguard online column explains how a 2022 FDA master protocol guidance has not kept pace with non-oncology basket trial developments...
FDA removes partial clinical hold against MacroGenics Phase 2 LINNET study evaluating the investigational cancer therapy lorigerlimab.
An FDA Matters column calls on FDA to fully enforce the laws against mass compounding of approved drugs that are not in shortage.
FDA warns Newport Beach, CA-based physician Ehsan Sadri about failing to follow the investigational plan in two clinical trials.
FDA plans a two-day public workshop next month aimed at improving how pregnancy registries are designed and used to assess the safety of drugs and bio...
Organogenesis says it has reached agreement with FDA that clears the way for a rolling BLA submission for its knee osteoarthritis product ReNu.
FDA warns Glens Falls, NY-based Medline Industries about Quality System violations in its manufacturing and assembly of cardiovascular procedure kits.
