Free speech mandates vacating off-label promotion conviction, says Second Circuit in United States v. Caronia
On December 3, 2012, the Court of Appeals for the Second Circuit issued an opinion in the matter of United States v. Caronia, which has received substantial attention in the national and pharmaceutical trade press. Hogan Lovells’ analysis of that opinion and its potential implications is available here.
On 26 September 2016, a new EU-US collaboration between the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) was announced. This new collaboration is ...06 October 2016
On 1 September 2016, the European Medicines Agency ("EMA") opened for public consultation a Draft revision to its Guideline on the assessment of clinical safety and efficacy in the...08 September 2016