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LSRO's Reduced Risk Review Core Committee met for the second time on the FASEB Campus, 9650 Rockville Pike, Bethesda MD, on March 23-24, 2005. The Core Committee members present were Alwynelle Ahl, Ph.D., D.V.M., Elizabeth L. Anderson, Ph.D., Nancy L. Buc, Esq., Carroll E. Cross, M.D., Louis D. Homer, M.D., Ph.D., Joseph V. Rodricks, Ph.D., Emanuel Rubin, M.D., Richard C. Schwing, Ph.D., and Richard Windsor, M.S., Ph.D., M.P.H (3/24 only). The LSRO staff members present were Catherine St. Hilaire, Ph.D., Mike Falk, Ph.D., Daniel Byrd, Ph.D., D.A.B.T., Amy Brownawell, Ph.D., Kara Lewis, Ph.D., Keith Lenghaus, Ph.D., Paula Nixon, Ph.D and Carmen Mones, B.A. Mike Falk and Keith Lenghaus made presentations during an information gathering session held on the first day of the meeting.
The goal of the meeting was to focus on scientific considerations in the evaluation of potential reduced-risk tobacco products and to develop questions for the State-of-the-Science Review Committees (SSRCs) to address during their deliberations.
Dr. Falk provided information on the FDA process for reviewing the scientific data for proposed health claims for foods and dietary supplements.
Dr. Lenghaus provided an overview of reduced-risk tobacco products and made a separate presentation on human smoking behaviors and nicotine compensation.
A review of the published literature on the testing of potential reduced-risk tobacco products was discussed, and the Core Committee was able to identify critical areas of inquiry for the SSRCs.
The next meeting of the Core Committee is scheduled for April 27-28, 2005 at the Marriott Residence Inn, Bethesda MD. The first part of the meeting (4/27, 8 am - 3 pm) is open to the public and will consist of presentations by invited speakers and individuals providing comments on the project. Details of the meeting can be found here.
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