Animal & Veterinary
REORGANIZATION WITHIN THE OFFICE OF NEW ANIMAL DRUG EVALUATION
by Joanne Kla
FDA Veterinarian Newsletter 2002 Volume XVI, No V
The Office of New Animal Drug Evaluation (ONADE) has just completed the first phase of a two-phase reorganization. The new structure collects all of the scientific review teams that previously reported directly to the Office Director, and incorporates them into a new Scientific Support and Generic Animal Drug Staff, headed by Dr. Gregg Claycamp (HFV-102). The Environmental Assessment Team, formerly located in the Division of Manufacturing Technologies, is officially moved (and renamed) under the reorganization to become the Environmental Safety Team in the new Scientific Support and Generic Animal Drug Staff. These changes are reflected in Chart A below. With the exception of the movement of the Environmental Safety Team, the Review Divisions in the Office are not directly affected by this reorganization.
Another change to the Scientific Support and Generic Animal Drug Staff is the recent addition of Dr. Larisa Rudenko. Dr. Rudenko joined the Risk Analysis Team as a Senior Advisor for Risk Analysis on July 29, 2002. Dr. Rudenko brings expertise in biotechnology risk analysis to collaborations with the Animal Biotechnology Working Group analyzing potential human, animal, and environmental risks associated with animal cloning and biotechnology, and to the Risk Analysis Team, working on antimicrobial resistance from food animal uses of antimicrobial drugs.
Before coming to CVM, Dr. Rudenko founded Integrative Biostrategies, LLC, a Washington-based firm working at the interface of biological sciences, regulatory affairs, policy and business decisions. Dr. Rudenko has been actively involved in the development of biotechnology risk assessment models beginning with evaluating the risk of antibiotic resistance arising from the use of kanamycin resistance as a selective marker for the Calgene FLAVR SAVR® tomato, developing applications for regulatory approvals for foods derived from transgenic microbes, plants, and animals. She recently served as a risk and scientific consultant to the Pew Initiative on Food and Biotechnology.
Dr. Rudenko received her A.B. degree form Bowdoin College and her Ph.D. in Cellular and Molecular Pharmacology from the State University of New York at Stony Brook. She is a Diplomate of the American Board of Toxicology.
When both phases of the reorganization are complete, the Office of New Animal Drug Evaluation (ONADE) will ultimately consist of the current five Divisions reporting to the ONADE Director and two new Staffs located within the Office of the Director. In addition to the Scientific Support and Generic Animal Drug Staff an Administrative and Technical Support Staff will be formed to collect all of the administrative/technical support teams that serve at the Office level under one Staff Director yet to be named. Chart B reflects the ONADE reorganization once it is complete.
Joanne Kla is a Consumer Safety Officer on CVM's Communications Staff.
SCIENTIFIC SUPPORT & GENERIC ANIMAL DRUG STAFF
RISK ANALYSIS TEAM
ENVIRONMENTAL SAFETY TEAM
SCIENTIFIC SUPPORT &
GENERIC ANIMAL DRUG STAFF
TECHNICAL SUPPORT STAFF