FDA Commissioner candidate Joseph Gulfo may have endeared himself to many agency reviewers with his call to end the breakthrough therapies program. But then again, his ideas for a multi-tiered approva
An unusual Senate hearing venue highlighted old arguments over FDA’s statutory standard for premarket approval and expanded access in the current political context of accelerating access for pediatric
IN VITRO DIAGNOSTICS Mergers & Acquisitions Opko Health Inc. Bio-Reference Laboratories Inc. Opko Health Inc. acquired publicly traded Bio-Reference Laboratories Inc. (BRLI; clinical laborator