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Results: 1-10 of 188

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The Food and Drug Administration recently released a draft guidance regarding the implementation of the 'deemed to be a licence' provision of the


New FDA Draft Guidance on Biosimilar Labeling Largely Follows Generic Drug Approach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On March 31, the U.S. Food and Drug Administration (FDA) published its long-awaited draft guidance, "Labeling for Biosimilar Products."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FDA Draft Guidance on BPCIA Transitional Provisions Would Rescind Innovator Exclusivities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The U.S. Food and Drug Administration (FDA) recently released draft guidance (Draft Guidance), entitled "Implementation of the 'Deemed to be a


Proposed Amendments to Singapore’s Pharmaceutical Laws
  • Sidley Austin LLP
  • Singapore
  • February 3 2016

Singapore's Health Sciences Authority (HSA) held its second consultation on proposed subsidiary legislation to consolidate regulatory controls for


Sidley Global Pricing newsletter - V4 2016
  • Sidley Austin LLP
  • United Kingdom, USA, France, Germany, India, Netherlands, Spain, Sweden, Australia, Belgium, Canada, China, European Union
  • January 27 2016

The Australian Pharmaceutical Benefits Pricing Authority (PBPA) ceased operations on April 1, 2014, in a move by the government to improve drug


New Guidance Reflects Heightened FDA Focus on Medical Device Cybersecurity
  • Sidley Austin LLP
  • USA
  • January 26 2016

On January 15, 2016, the Food and Drug Administration (FDA) issued new guidance that, for the first time, recommends routine postmarketing


FDA continues scrutiny of direct-to-consumer genetic testing
  • Sidley Austin LLP
  • USA
  • January 13 2016

The Food and Drug Administration (FDA) recently released three untitled letters from the Office of In Vitro Diagnostics and Radiological Health (OIR