The career staff at the US Food and Drug Administration (FDA) will be thinking hard about alternative potential avenues for the regulation of laboratory developed tests (LDTs), Michael Ryan, partner at McDermott Will & Emery, told the audience at the law firm’s annual European Health and Life Sciences Symposium, held in London on 3 April.
Ryan continued, “I would not be surprised to see the FDA try to take enforcement action against certain types of...