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On Pre-emption, OTC Rule Among Signs Tipping Obama Administration’s Hand

This article was originally published in The Tan Sheet

Executive Summary

FDA has not altered its support of pre-emption in product liability suits but there are signs it will happen under the Obama administration

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In Brief

FDA clarifies pre-emption on OTC labeling

Pharma Outside the Fray As Obama Re-Evaluates Bush’s Pre-emption Policy

The good news for drug firms about President Obama's memo curtailing federal pre-emption state laws: It will not have any real impact on industry. The bad news: It will not matter because pre-emption in the drug arena already took a body blow in the Supreme Court's Wyeth v. Levine ruling

FDA Expands Acetaminophen, NSAID Labeling Beyond Tentative Final Rule

FDA's final rule for OTC products containing acetaminophen or nonsteroidal anti-inflammatory drugs requires warnings and revisions that go beyond changes the agency proposed in a 2006 tentative final rule

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