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Results: 1-10 of 91

FDA Issues Draft Guidance on Orphan Drug Designation in Pediatric Subpopulations
  • Latham & Watkins LLP
  • USA
  • December 21 2017

On December 20, 2017, the US Food and Drug Administration (FDA or Agency) issued draft guidance stating that the Agency no longer intends to grant


FDA Reauthorization Act Aims to Speed Product Reviews Through User Fee Funding
  • Latham & Watkins LLP
  • USA
  • August 9 2017

On August 3, 2017, the Senate passed the Food and Drug Administration Reauthorization Act (FDARA or the Act) by a vote of 94-1.1 The FDARA bill had


FDA Works to Increase Competition Under Commissioner’s Drug Competition Action Plan
  • Latham & Watkins LLP
  • USA
  • June 29 2017

In recent weeks, the US Food and Drug Administration (FDA or the Agency) has taken a series of steps under FDA Commissioner Scott Gottlieb’s Drug


Federal Circuit Returns the On-Sale Bar to Status Quo for AIA Patents
  • Latham & Watkins LLP
  • USA
  • June 7 2017

The Leahy-Smith America Invents Act (AIA) is widely considered the most significant overhaul of US patent law since the Patent Act of 1952


FDA Issues Draft Guidance on Biosimilar Interchangeability
  • Latham & Watkins LLP
  • USA
  • January 27 2017

On January 18, 2017, the US Food and Drug Administration (FDA or Agency) issued its highly anticipated draft guidance on demonstrating


21st Century Cures Act Brings Medicare Reimbursement and Policy Changes in 2017
  • Latham & Watkins LLP
  • USA
  • January 3 2017

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act) with strong bipartisan support. The Act includes several


President Obama Signs the 21st Century Cures Act Into Law
  • Latham & Watkins LLP
  • USA
  • December 13 2016

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), which Congress passed with strong bipartisan support


Supreme Court Denies Cert in Lamictal Pay-For-Delay Litigation
  • Latham & Watkins LLP
  • USA
  • November 15 2016

On November 7, 2016, the Supreme Court of the United States declined to hear the petition of GlaxoSmithKline LLC (GSK), Teva Pharmaceutical Industries


FDA Issues Final Rule on Abbreviated New Drug and 505(b)(2) Applications
  • Latham & Watkins LLP
  • USA
  • October 6 2016

On October 6, 2016, the US Food & Drug Administration (FDA or the Agency) published a 79-page final rule (the Final Rule) in the Federal Register


Generic vs. Branded Liability: Mensing Holds Sway Until FDA Completes Rulemaking
  • Latham & Watkins LLP
  • USA
  • June 2 2016

The U.S. Food and Drug Administration (FDA) recently announced it will not finalize a rule to allow generic drug manufacturers to independently