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Results: 1-10 of 398

New medical device regulations in Japan

  • Sidley Austin LLP
  • -
  • Japan
  • -
  • October 23 2014

Major amendments to Japan's Pharmaceutical Affairs Act of 1960 (the "Act") will come into effect on November 25, 2014. One of the purposes of these

OIG issues report and advisory bulletin on manufacturer-sponsored coupons

  • Sidley Austin LLP
  • -
  • USA
  • -
  • October 22 2014

On September 19 2014 the US Department of Health and Human Services' Office of Inspector General (OIG) issued a controversial report entitled

Health and welfare plan year-end action items

  • Sidley Austin LLP
  • -
  • USA
  • -
  • October 13 2014

As 2014 comes to an end, health plan sponsors most certainly are taking actions to ensure compliance with the Affordable Care Act ("ACA") employer

UK introduces partners’ right to time off for ante-natal appointments

  • Sidley Austin LLP
  • -
  • United Kingdom
  • -
  • October 7 2014

The UK has introduced a new right to unpaid time off to accompany a pregnant woman to ante-natal appointments. This right, contained in the Children

European Medicines Agency adopts long-awaited policy on publication of clinical data

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • October 3 2014

On October 2, 2014, the European Medicines Agency (EMA) published its long-awaited policy on the publication of clinical data for medicinal products

DOJ files FCA suit against PODs and physician-investors

  • Sidley Austin LLP
  • -
  • USA
  • -
  • September 26 2014

In recent years, the growing number of physician-owned distributors ("PODs")medical device distributors owned at least in part by physicians

Hospitals move to dismiss DOJ’s “untimely refund” overpayment suit

  • Sidley Austin LLP
  • -
  • USA
  • -
  • September 26 2014

We previously reported on the Department of Justice's ("DOJ's") and the New York Attorney General's pioneering suits against a provider network

OIG issues report on manufacturer-sponsored coupons and companion Special Advisory Bulletin

  • Sidley Austin LLP
  • -
  • USA
  • -
  • September 23 2014

On September 19, 2014, the U.S. Department of Health and Human Services' Office of Inspector General (OIG) issued a controversial report entitled

FDA affirms permissive comparative claim policies, while establishing foundation for restrictive guidance

  • Sidley Austin LLP
  • -
  • USA
  • -
  • September 22 2014

Food and Drug Administration (FDA) officials recently affirmed that prescription drug manufacturers may make comparative promotional claims regarding

EU Commission shifts responsibility for pharmaceuticals, medical devices, biotechnology and cosmetics

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • September 18 2014

On September 10, 2014, European Commission President-elect Juncker issued a press release unveiling his new EU executive team and announcing a