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FDA guidance

This article was originally published in The Tan Sheet

Executive Summary

"Submission of Abbreviated Reports and Synopses in Support of Marketing Applications" guidance, expected to appear in the Sept. 13 Federal Register, describes when studies that are part of an NDA may be submitted to FDA in abbreviated form and describes the format abbreviated submissions should follow. The agency estimates the resulting reduction in burden for industry will be 300 hours. A draft of the guidance appeared in the Sept. 21 Federal Register (1"The Tan Sheet" Sept. 28, 1998, p. 24). Comments may be submitted at any time
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