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Results: 1-10 of 195

FDA Overhauls Design and Content of Nutrition Labeling
  • Sidley Austin LLP
  • USA
  • May 26 2016

On May 20, 2016, the Food and Drug Administration (FDA) announced the release of two final rules amending its nutrition labeling regulations. The


FDA Issues Draft Guidance on Additive Manufactured Devices
  • Sidley Austin LLP
  • USA
  • May 19 2016

On May 10, the U.S. Food and Drug Administration (FDA) issued draft guidance to provide its initial thoughts on regulatory requirements for additive


FDA's Final Medical Foods Guidance Maintains Restrictions on Category
  • Sidley Austin LLP
  • USA
  • May 16 2016

On May 12, 2016, the Food and Drug Administration (FDA) finalized its August 2013 Draft Guidance, "Frequently Asked Questions About Medical Foods


Significant Changes by the VA in Country of Origin Requirements for Federal Supply Schedule Contracts
  • Sidley Austin LLP
  • USA
  • May 3 2016

Recently, the Department of Veterans Affairs (VA) published a significant change of policy with respect to VA Federal Supply Schedule (FSS) contracts


Singapore’s New Risk-Based Approach for Medical Devices Undergoing Corrective Action
  • Sidley Austin LLP
  • Singapore
  • April 29 2016

As of April 18, Singapore’s Health Sciences Authority (HSA) will adopt a new approach by introducing a risk management process for deciding


FDA draft biologics guidance would rescind innovator exclusivities
  • Sidley Austin LLP
  • USA
  • April 13 2016

The Food and Drug Administration recently released a draft guidance regarding the implementation of the 'deemed to be a licence' provision of the


New FDA Draft Guidance on Biosimilar Labeling Largely Follows Generic Drug Approach
  • Sidley Austin LLP
  • USA
  • April 7 2016

On March 31, the U.S. Food and Drug Administration (FDA) published its long-awaited draft guidance, "Labeling for Biosimilar Products." While the


Five Things To Know About The Amarin Settlement
  • Sidley Austin LLP
  • USA
  • March 31 2016

On March 8, 2016, Amarin Pharma, Inc., advised Judge Paul Engelmayer of the United States District Court for the Southern District of New York that


FDA Moves to Ban Powdered Gloves
  • Sidley Austin LLP
  • USA
  • March 28 2016

On March 22, the U.S. Food and Drug Administration (FDA) published a Federal Registernotice proposing to ban powdered surgeons' gloves, powdered


FDA Draft Guidance on BPCIA Transitional Provisions Would Rescind Innovator Exclusivities
  • Sidley Austin LLP
  • USA
  • March 24 2016

The U.S. Food and Drug Administration (FDA) recently released draft guidance (Draft Guidance), entitled "Implementation of the 'Deemed to be a