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Goodbye to Generic Preemption? FDA Publishes Proposed Rule

Today, the U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule in the Federal Register in an effort to “create parity” between brand-name and generic manufacturers for their labeling obligations. 78...more

Mensing and Its Impact on State-Law-Based Claims Against Generic Drug Manufacturers

Following the U.S. Supreme Court’s five–four decision in PLIVA, Inc. v. Mensing,1 it appears doubtful that many state-law-based claims against generic drug manufacturers remain viable. In Mensing, the Supreme Court held that...more

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