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This article was originally published in The Tan Sheet

Executive Summary

Industry-proposed disclaimer on product liability relevance of NDA withdrawals is "incorrect on the facts" and "outside the scope of FDA's jurisdiction and authority," Philadelphia plaintiff law firm Levin, Fishbein, Sedran & Berman assert in Sept. 28 letter. "FDA has not conducted any factual investigation of the marketing practices of the various drug companies which manufactured and distributed PPA products and it has no basis for determining whether such companies were negligent or breached any warranties made to consumers," firm says. Several companies requested FDA state that any order withdrawing PPA approvals is not intended to be used as evidence in lawsuits (1"The Tan Sheet" Sept. 24, In Brief)

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