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FDA first-quarter 1988 NME approvals

Executive Summary

FDA Commissioner Young has stated publicly that "a substantial number" of approvals are likely to occur in the first three months of 1988 ("The Pink Sheet" Jan. 11, p. 10). At a Jan. 19 analysts meeting in New York, Warner-Lambert Chairman Joe Williams said that, based on a personal conversation with the commissioner, he believes the agency could approve 11 NMEs by March 31. Young has publicly committed the agency to try to spread out NDA approvals throughout the calendar year.
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