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Results: 1-10 of 178

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
  • Spain, Sweden, United Kingdom, USA, China, European Union, France, Germany, India, Netherlands, Australia, Belgium, Canada
  • 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


Ten Steps Life Sciences Companies Should Take to Address Global Challenges in 2016
  • Sidley Austin LLP
  • Global
  • January 7 2016

New pricing regimes in the EU and China are heavily focused on comparative effectiveness, while the U.S. will also see new cost-constraining


Revised Guidance: Change Notification for Registered Medical Devices in Singapore
  • Sidley Austin LLP
  • Singapore
  • December 24 2015

On November 25, 2015, the Medical Device Branch of the Health Sciences Authority of Singapore released the updated guidance on the change


Alleged Manipulation of Compendia Process Held Insufficient to Withstand Summary Judgment on Off-Label Marketing Claims
  • Sidley Austin LLP
  • USA
  • December 18 2015

A district court granted summary judgment to Solvay Pharmaceuticals on claims that it influenced the public body of scientific research in order to


China launches three-year trial program to implement new market authorization holder system for drugs
  • Sidley Austin LLP
  • China
  • November 11 2015

On Nov. 4, the China National People's Congress authorized the State Council to launch a three-year trial program to implement the market


FDA changes course on INDs for food and supplement studies, but not for cosmetics
  • Sidley Austin LLP
  • USA
  • October 30 2015

FDA announced today that it is indefinitely staying portions of the Guidance, "Investigational New Drug Applications - Determining Whether Human


District court refuses to certify “fraud on the FDA” claims for interlocutory appeal
  • Sidley Austin LLP
  • USA
  • October 5 2015

A judge in the Western District of Texas recently departed from a magistrate judge’s recommendation, ruling that the novelty of the relator’s FCA