CDER Move To White Oak Site Delayed Until July
This article was originally published in The Pink Sheet Daily
Executive Summary
The move, which had been scheduled for April, has been pushed back because the building is not ready, FDA says. The CDER reorganization is also being delayed to coincide with the move.
The Center for Drug Evaluation & Research's move to FDA's White Oak, Md. facility has been delayed until July because building construction has fallen behind schedule, the agency said. The agency originally planned for the move to take place in April (1 (Also see "FDA Reorganization Of New Drug Office Would Split Neuropharmaceutical Division" - Pink Sheet, 20 Oct, 2004.)). Reorganization of CDER's Office of New Drugs, including the creation of an Office of Oncology Drug Products and the separation of the Division of Neuropharmacological Drugs Products into two divisions, will also be delayed until July to coincide with CDER's move into the new facility. During a speech at the U.S. Pharmacopeia meeting in Washington, D.C. March 11, Acting Commissioner Lester Crawford said the White Oak facility is "on target and on course." "We have five buildings now that are in various stages of completion, so what we have is like a mini-university, which, when completed in 2008, will surely be the most impressive facility any regulatory body has in the world," Crawford said. "That is as it should be." - Lee Kalowski |