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FCA podcast episode: New scrutiny of “false” medical judgments
  • Hogan Lovells
  • USA
  • February 13 2019

In this episode, we'll visit with Hogan Lovells partner Jonathan Diesenhaus, from our Washington, D.C., office, and counsel Julia McLetchie, from our


New medical device regulations: what liability do notified bodies face?
  • Hogan Lovells
  • European Union, Italy
  • February 13 2019

Under the EU Medical Device Regulation and the EU In Vitro Diagnostic Medical Device Regulation, organisations that want be recognised as notified


Update EMA relocation to Amsterdam & regulatory changes for EU centrally approved medicinal products
  • Hogan Lovells
  • United Kingdom, European Union
  • February 12 2019

As the European Medicines Agency (EMA) is relocating from London to Amsterdam in view of Brexit, several developments took place during the last few


Trump administration proposes ambitious AKS rewrite on drug rebates, but needs answers to big questions
  • Hogan Lovells
  • USA
  • February 8 2019

In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs


Would you like an extra application with that? FDA mulls requiring dual applications for combination products
  • Hogan Lovells
  • USA
  • February 8 2019

On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level


New Brexit Q&A provides several examples in relation to the “placing on the EU market”of products including medical devices
  • Hogan Lovells
  • United Kingdom, European Union
  • February 6 2019

On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the


FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents, seek public comment
  • Hogan Lovells
  • USA
  • February 4 2019

FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved


HHS OIG: Smartphone loaner to needy patients may not violate Anti-Kickback Statute
  • Hogan Lovells
  • USA
  • February 1 2019

On Tuesday, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published Advisory Opinion No. 19-02, advising that


New Belgian legislation on the distribution of medical devices
  • Hogan Lovells
  • Belgium
  • January 28 2019

Today, the Belgian Minister of Health published the new Royal Decree of 19 December 2018 on the liberalisation of the distribution circuit for medical


European Commission publishes factsheet on the (in vitro) medical devices procurement ecosystem
  • Hogan Lovells
  • European Union
  • January 25 2019

The European Commission has published a factsheet addressed to organisers of public tenders involving medical devices. The goal of the factsheet is to