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AIDS, Not PDUFA Pressure, Underlies Post-Market Safety Event Surge – Lutter

Executive Summary

DURHAM, N.C. - Any surge in FDA post-market safety actions stems from the rapid approval of AIDS drugs during the 1990s, and not errors made as a result of review time constraints created by user fee deadlines, Deputy Commissioner for Policy, Planning and Preparedness Randall Lutter maintained June 23

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