Three stakeholders express support for FDA’s LEADER 3D rare disease educational materials and suggest ways to improve them.
FDA warns Newport Beach, CA-based physician Ehsan Sadri about failing to follow the investigational plan in two clinical trials.
Three stakeholders express support for FDA’s LEADER 3D rare disease educational materials and suggest ways to improve them.
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 biologics during pregnancy.
Organogenesis says it has reached agreement with FDA that clears the way for a rolling BLA submission for its knee osteoarthritis product ReNu.
