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Biopharmaceutical classification

Executive Summary

Final FDA guidance should issue in the next few weeks, Office of Pharmaceutical Science Acting Director Helen Winkle said May 15 at the National Association of Pharmaceutical Manufacturers mid-year meeting in Newark, N.J. Center for Drug Evaluation & Research Director Janet Woodcock, MD, "has already signed the guidance," Winkle said. A training session will be held June 19. The draft was published in February 1999 (1"The Pink Sheet" Feb. 22, 1999, p. 24)

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