This article was originally published in The Tan Sheet
Rep. Rosa DeLauro, D-Conn., wants FDA to halt efforts to establish the Reagan-Udall Foundation, a non-profit advisory body established by the recently enacted FDA Amendments Act. "The potential for pressure on FDA staff from Reagan-Udall Foundation-endorsed research is enormous," the chair of the House subcommittee overseeing FDA's budget writes in a Nov. 1 letter to Commissioner Andrew von Eschenbach. The foundation, to be funded from donations, patent revenue and FDA's budget, is tasked to work with FDA on its critical path initiative and other product development efforts (1"The Tan Sheet" Oct. 8, 2007, In Brief). By law, four members of the yet-unnamed 14-person foundation board must be from the drug, device, food, cosmetic and biotech industries...
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Brookings Institution's Engelberg Center for Healthcare Reform Director Mark McClellan returns to his FDA bailiwick as chairman of the Reagan-Udall Foundation. The former FDA commissioner will lead the private organization established by the FDA Amendments Act to advance the agency's Critical Path initiative and identify unmet scientific needs. Other Reagan-Udall board members announced Nov. 16 include representatives from Genzyme and Johnson & Johnson. House Agriculture-FDA Appropriations Chairwoman Rosa DeLauro, D-Conn., has requested FDA stop activities related to the creation of the foundation until the agency addresses issues of industry influence (1"The Tan Sheet" Nov. 12, 2007, In Brief)...
Patient and consumer advocacy groups, professional scientific and medical societies, and trade groups are encouraged to submit nominations for candidates to serve on the board of directors for the Reagan-Udall Foundation, which is dedicated to modernizing medical, veterinary, food and cosmetic product development to accelerate innovation and enhance product safety, the agency announces in Oct. 3 Federal Register notice. Nominations for the foundation should be submitted by Oct. 15; the initial board is to be appointed no later than 30 days after the Sept. 27 enactment of the FDA reauthorization bill (1"The Tan Sheet" Oct. 1, 2007, p. 11). The board will include 14 members, five selected through nominations and nine by the National Academy of Sciences...
Abbott is encouraged by results from two studies of its Proclaim XR neurostimulation system for chronic pain, presented at the annual North American Neuromodulation Society (NANS) meeting in Las Vegas. See what Steven Falowski of Neurosurgical Associates of Lancester in Pennsylvania said about it here.
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