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UK retailers remove baby sleep positioners from sale
  • Leigh Day
  • United Kingdom
  • October 9 2017

Leading UK retailers have halted the sale of baby sleep positioners following a warning from the US Food and Drug Administration, the FDA, that 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

New FDA Final Guidance on Medical Device Panel Meetings Provides Certain Changes to Timelines and Procedures
  • Hogan Lovells
  • United Kingdom
  • September 20 2017

On September 1, 2017, the Food and Drug Administration (FDA or the Agency) released a final guidance document discussing the procedures for Medical

FDA approves first GM individualised Cell Therapy
  • Bristows
  • United Kingdom
  • September 20 2017

Novartis has received FDA approval for its CAR-T cell therapy, marketed as Kymriah, for the treatment of a particular type of blood cancer, acute

"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

Is there such a thing as Substitution or Interchangeability for Biosimilars?
  • Bristows
  • United Kingdom
  • August 11 2017

Biological medicinal products have rapidly become one of the fastest growing areas of medicine and for many conditions they offer a new and more

Essure, the alternative to tubal ligation for UK women, to be discontinued in September 2017
  • Leigh Day
  • USA, United Kingdom, Canada
  • June 21 2017

The German multinational chemical and pharmaceutical company Bayer AG have confirmed several changes to the supply and distribution of the Essure

Food, Dietary Supplement & Cosmetics Regulatory Update Vol. IV, Issue 1
  • Jones Day
  • USA, United Kingdom, European Union
  • February 16 2017

On January 20, 2017, the Trump Administration issued a memorandum "for the Heads of Executive Departments and Agencies" requesting the "regulatory

Steptoe Cyberlaw Podcast - News Roundup
  • Steptoe & Johnson LLP
  • USA, United Kingdom
  • January 17 2017

Posse Comitatus: Latin for “Get off my turf”? Would it violate the Posse Comitatus Act to give DOD a bigger role in cybersecurity? Michael Vatis and

The 21st Century Cures Act
  • Arnold & Porter Kaye Scholer LLP
  • USA, United Kingdom
  • December 16 2016

Following a multi-year, bipartisan, and bicameral effort to accelerate the pace of the discovery, development, and delivery of new treatments