US FDA Reorg Emphasizes Office of Therapeutic Biologics and Biosimilars
Executive Summary
Final reorganization structure includes new office within OND to coordinate review of biologics and biosimilars applications, as well as new oncology and hematology divisions.
You may also be interested in...
FDA’s Gottlieb Says His Departure Won’t Stop Forward Progress On Key Initiatives
Outgoing commissioner say he has 'extreme confidence' in soon-to-be-acting Commissioner Ned Sharpless and other agency leaders, and expects initiatives advanced during his tenure will be ‘encapsulated and enshrined in regulation and policy’ because they are built on a solid administrative record.
US FDA Reorg: Defining The “Central” Purpose Of A Commissioner
Scott Gottlieb will formally implement a new structure for the Office of the Commissioner just days before he departs from the job. That may be odd timing, but the new structure is in many ways a perfect capstone for Gottlieb’s tenure.
Gottlieb Touts US FDA's Organizational Structure For Advancing Policies During His Tenure
Outgoing FDA commissioner said his direct contact with center directors helped agency advance policies and helped centers solve their problems.