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Results: 1-10 of 60

PreemptionFailure-to-Warn Claims in Pharmaceutical Cases
  • Mayer Brown
  • USA
  • June 28 2018

In a sequel to Wyeth v. Levine, 555 U.S. 555 (2009), the Supreme Court has granted certiorari to decide whether state-law failure-to-warn claims are


Biologics Price Competition and Innovation ActNotice Requirement
  • Mayer Brown
  • USA
  • June 12 2017

The 2009 Biologics Price Competition and Innovation Act, a component of the Affordable Care Act, created an abbreviated regulatory pathway for the FDA


FDA Issues Guidance on Interchangeable Biosimilars
  • Mayer Brown
  • USA
  • January 25 2017

The US Food and Drug Administration ("FDA") has issued long-awaited draft guidance addressing the standards for demonstrating interchangeability of


US Federal Trade Commission Wants Marketers of Homeopathic Remedies to Disclose Lack of Scientific Evidence
  • Mayer Brown
  • USA
  • November 30 2016

On 15 November 2016, the US Federal Trade Commission (“FTC” or the “Commission”) issued an “Enforcement Policy Statement” (“Policy Statement”) to


FDA Finalizes Significant Labeling Rules, Issues Guidance on Evaporated Cane Juice
  • Mayer Brown
  • USA
  • May 27 2016

Within a single week, the US Food and Drug Administration (FDA) released two final rules and a final guidance document that will have significant


FDA Continues to Address Opioid Abuse
  • Mayer Brown
  • USA
  • April 13 2016

The Centers for Disease Control and Prevention (CDC) reports that “the United States is in the midst of an opioid overdose epidemic,” noting that


FDA Seeks Comment on Draft Guidance for Manufacture of Interoperable Medical Devices
  • Mayer Brown
  • USA
  • February 5 2016

On January 26, 2016, the US Food and Drug Administration (FDA) issued draft guidance entitled Design Considerations and Pre-market Submission


US FDA Issues Warning Letter to Stem Cell Treatment Centers
  • Mayer Brown
  • USA
  • January 20 2016

The US Food and Drug Administration ("FDA") has sent a Warning Letter covering three physician-operated stem cell treatment centers in California


US Food and Drug Administration Issues Final Rules Addressing Imported Food Safety
  • Mayer Brown
  • USA
  • December 9 2015

The US Food and Drug Administration (FDA) recently issued two final rules intended to increase the safety of food imported into the United States


Supreme Court denies cert in highly watched FCA caseregulatory violation must be related to claim for payment
  • Mayer Brown
  • USA
  • October 8 2014

This week, the Supreme Court denied the qui tamplaintiff's petition for certiorari in United States ex. Rel. Rostholder v. Omnicare, Inc., a False