NDMA opposes FDA's OTC office reorganization to division under CDER restructuring.
This article was originally published in The Rose Sheet
Executive Summary
NDMA OBJECTS TO POTENTIAL DEMOTION OF OTC OFFICE TO DIVISION LEVEL under a reorganization plan proposed by the Center for Drug Evaluation & Research. At a Food & Drug Law Institute meeting May 23 in Washington, DC, Nonprescription Drug Manufacturers Association Senior VP and General Counsel Daniel O'Keefe declared: "We strongly urge for the Office of OTC Drug [Evaluation] to be retained" as an office. The CDER proposal would place OTC operations in a division within a newly formed Office of Drug Evaluation 5 ("The Rose Sheet" April 17, In Brief).