CDER Reorganizes

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ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration?s Center for Drug Evaluation and Research (CDER, Rockville, MD) formally put into action its reorganization plan, effective May 15.

The US Food and Drug Administration's Center for Drug Evaluation andResearch (CDER, Rockville, MD, formally put into action itsreorganization plan, effective May 15.

Per the goals announced in last fall's State of CDER address, thereorganization is intended to support its Critical Path Initiative.Among the changes is the creation of the Office of TranslationalSciences to include the Office of Clinical Pharmacology and the Officeof Biostatistics; elevating the Office of Surveillance and Epidemiology(formerly the Office of Drug Safety) to report to the center director;appointing an associate center director for safety policy andcommunication to focus on broad drug safety policy and safetycommunication; moving the pediatric drug development review staff tothe Office of New Drugs; and realigning the Division of ScientificInvestigations from the Office of Medical Policy to the Office ofCompliance.

In an official memorandum, CDER Director Steven Galson said, "I amconfident that these changes will lead to greater improvements inregulatory and drug development science and in how we evaluate andensure the safety and efficacy of the products we regulate, and willresult in greater protections for patients and consumers who depend onus everyday."


Source: "The Pink Sheet,"68 (21), 10 (2006).