• US FDA to reduce backlog of generic drug applications, increase inspections
  With US Food and Drug Administration (FDA) planning to work towards reducing the backlog of generic drug applications under the Generic Drug User Fee Act (GDUFA), Indian pharmaceutical companies have however cited challenges like approval time for abbreviated new drug applications (ANDAs)– the applications filed for generic drugs and heightened inspection activities, as GDUFA requires stepping up number of foreign inspections.
  in Public bookmarks with clinical organization research services trial trials

« Previous
clinical from all users