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Food, Dietary Supplement & Cosmetics Update Vol. V, Issue 1
  • Jones Day
  • USA, European Union
  • January 12 2018

On January 4, 2018, the U.S. Food and Drug Administration ("FDA") issued a guidance announcing that it does not intend to enforce certain provisions


2017 Biosimilar Approvals in Europe
  • Patterson Belknap Webb & Tyler LLP
  • European Union
  • December 21 2017

The European biosimilar market has expanded at record pace in 2017. The EMA approved marketing of sixteen biosimilar products referencing seven


Food, Dietary Supplement & Cosmetics Update Vol. IV, Issue 7
  • Jones Day
  • USA, European Union
  • November 16 2017

The USDA Inspector General ("IG") reviewed the Agricultural Marketing Service's ("AMS") process used in determining whether exporting countries'


FDA to Rely on Drug Inspections Performed by Certain European Regulatory Authorities Beginning November 1, 2017
  • Hogan Lovells
  • European Union
  • October 31 2017

Earlier today, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the


UK MHRA Issues New Guidance on Human Factors and Usability Engineering for Medical Devices
  • Hogan Lovells
  • United Kingdom, European Union
  • September 22 2017

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on taking human factors into account when designing


Global Privacy & Cybersecurity Update Vol. 15
  • Jones Day
  • USA, European Union, Global
  • September 13 2017

On June 19, the Federal Trade Commission ("FTC") submitted comments to a working group organized by the Department of Commerce's National


Update: How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA, European Union
  • September 6 2017

As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S


The legal and regulatory challenges of getting a biosimilar product to market
  • CMS Cameron McKenna Nabarro Olswang LLP
  • USA, European Union
  • August 30 2017

The global biosimilars market is expected to reach $10.9 billion by 2021, according to the Biosimilars Global Forecast


"Miracle Gel" Not a Salon Gel Manicure, Ad Board Says
  • Shook Hardy & Bacon LLP
  • USA, United Kingdom, European Union
  • August 30 2017

In an appeal from a ruling by the National Advertising Division (NAD), the National Advertising Review Board (NARB) upheld a recommendation that Coty


FDA, EU Regulators Agree to Share Unredacted Inspection Reports and Other Confidential Information
  • Hogan Lovells
  • USA, European Union
  • August 25 2017

The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission - DG Sante (DG Sante), signed a new