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Fewer PMA Approvals In FY 1998 Anticipated By Device Center's Alpert

This article was originally published in The Gray Sheet

Executive Summary

FDA expects to approve fewer than 40 original premarket approval applications in fiscal year 1998 (ending Sept. 30), down from the prior "banner year" in which the agency okayed 48, Office of Device Evaluation Director Susan Alpert forecast at a recent Food and Drug Law Institute meeting in Washington, D.C.

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