Posted 04 March 2014
By Alexander Gaffney, RAC
The US Food and Drug Administration's (FDA) sprawling White Oak campus will soon absorb one of the agency's largest main regulatory divisions, it has announced
The White Oak campus, located in Silver Spring, MD, is meant to consolidate all of FDA's headquarter operations in one place. Previously, FDA has offices throughout the Washington, DC metro area, making it difficult for different divisions of FDA to meet with one another in person.
Starting in May 2014, FDA's Center for Biologics Evaluation and Research (CBER) is set to join the growing campus. The center is presently split between multiple locations in the Maryland cities of Rockville and Bethesda.
The move, announced in a Federal Register announcement on 4 March 2014, will take approximately eight weeks to complete.
The move will also have implications for members of the biotechnology industry. While the move will have no effect on CBER's electronic submissions gateway (ESG), all paper-based applications will need to be sent to its new mailing address at White Oak.
The move could also affect review time frames, though FDA said it will be making "every effort" to meet its user fee deadlines and minimize any delays due to the move.
"Should delays affecting receipt and review of applications and other submissions occur, we intend to update the FDA website as needed," FDA wrote.
CBER's collection of lot samples may be impacted the most by its move. "Because of the relocation of CBER's Sample Custodian … CBER will not be able to receive lot release samples during the 2 weeks surrounding this personnel move," it said. Industry will therefore need to release samples to CBER either before the move, or wait until its sample custodian is able to set up a new office.
Information about the move will be made available online on FDA's website.
Federal Register Notice