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Results: 1-10 of 36

Branded Biologic Products Lose 180 Days of Patent Exclusivity in Unanimous Decision From Supreme Court
  • Baker & Hostetler LLP
  • USA
  • June 16 2017

On June 13, 2017, the U.S. Supreme Court issued its opinion in Sandoz v. Amgen. In doing so, it answered two questions raised under the Biologics


Health Law Update - May 18, 2017
  • Baker & Hostetler LLP
  • USA
  • May 18 2017

Welcome to this week's edition of the Health Law Update. In this Issue Capitol Hill Healthcare Update Senate Panel OKs FDA User Fees Legislation


FDA Publishes Guidance on Off-Label Use Communications
  • Baker & Hostetler LLP
  • USA
  • March 9 2017

The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents and a memorandum related to off-label communications and


Human Drug Compounding: FDA Issues Four Guidance Documents
  • Baker & Hostetler LLP
  • USA
  • January 6 2017

FDA had a busy holiday season, issuing two final guidance documents and two draft guidance documents for industry related to human drug compounding


21st Century Cures: Ambitious Medical Innovation Bill Has Broad Focus
  • Baker & Hostetler LLP
  • USA
  • December 19 2016

In a health policy landscape fraught with partisan rancor, congressional members from both sides of the aisle came together to pass the 21st Century


Health Law Update - December 15, 2016
  • Baker & Hostetler LLP
  • USA
  • December 15 2016

Welcome to this week's edition of the Health Law Update. In this Issue: 21st Century Cures: Not Just a Biomed Bill 21st Century Cures: Ambitious


Five Types of Exclusivities
  • Baker & Hostetler LLP
  • USA
  • February 8 2016

Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of


First Amendment right to off-label promotion has pandora’s box been opened for FDA?
  • Baker & Hostetler LLP
  • USA
  • September 16 2015

A handful of recent court decisions, including one issued just last month, seems to have potentially cracked open the door for pharmaceutical


How far is too far? Court rules for Amarin in off-label marketing fight against FDA
  • Baker & Hostetler LLP
  • USA
  • August 13 2015

Drugmaker Amarin Pharma, Inc. (Amarin), recently received a victory in its fight against the Food and Drug Administration (FDA). On August 7, 2015


FDA investigates children’s cough and cold medication with codeine amid safety concerns
  • Baker & Hostetler LLP
  • USA
  • July 16 2015

In the wake of the European Medicines Agency's (EMA) recently announced warning against giving codeine to children under 12 years old, the FDA