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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