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  • when finalized, will replace the 1987 guidance.The FDA received feedback from numerous groups and individuals, including Russell E. Madsen, president of the consulting company The Williamsburg Group (Gaithersburg, Md.) and a former science and technology executive at the PDA. In general, it is a good document and improves on the '87 guidance in several ways; but in terms of its scope, it goes to
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