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FDA inspections of tissue banks remain a work in progress, and no clear path yet exists for procuring human tissues for biomedicine or drug development. Emily Waltz investigates.
The newly passed US Food and Drug Administration's (FDA) Amendments Act (FDAAA) sets the stage for key improvements to postmarketing surveillance as well as the preapproval process.
Years of tinkering with the mouse immune system genes has finally produced a winner, with the approval of the first fully human monoclonal antibody made in a mouse. A real breakthrough or an incremental improvement? Christopher Thomas Scott investigates.