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Changes being effected to drug labeling regime: FDA releases proposed pathway for generic safety updates
  • Jones Day
  • USA
  • December 6 2013

On November 13, the U.S. Food and Drug Administration ("FDA") published a proposed rule concerning "procedures for application holders of an approved


FDA proposes drug safety warning rule that may eliminate preemption defenses in some failure-to-warn cases
  • Jones Day
  • USA
  • November 15 2013

In a highly anticipated move, the U.S. Food and Drug Administration ("FDA") has proposed amending its regulations to permit abbreviated new drug