New FDA biosimilars office, flatter Office of Commissioner finalized

When Ned Sharpless arrives at FDA headquarters as acting commissioner on April 8, his name will be placed at the top of an organizational chart that looks very different from the structure that was in place when Scott Gottlieb arrived in May 2017.

Gottlieb and Center for Drug Evaluation and Research (CDER) Director Janet Woodcock have flattened FDA’s organization, and are realigning CDER so it is managed based more on diseases and conditions and less on oversight functions...