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Results: 1-10 of 62

US FDA Issues New Guidance for Digital Health
  • Baker McKenzie
  • USA
  • December 26 2017

With the increasing prevalence of digital health products and technology, the US Food and Drug Administration (US FDA) has launched several new pieces


FDA And 3D Printing What Will The Regulatory Regime Become?
  • Baker McKenzie
  • USA
  • December 18 2017

The US Food and Drug Administration (FDA) already has had its regulatory eye on 3D printing for some time. The Agency already has evaluated and


Healthcare goes digital but regulation hard to disrupt
  • Baker McKenzie
  • USA, Global
  • October 28 2017

Healthcare technology is at a pivotal moment in its development. The healthcare industry is primed to take advantage of the innovative tools that


International Trade Compliance Update - October 2017
  • Baker McKenzie
  • USA, Global
  • October 10 2017

On September 5, 2017, United States Trade Representative Robert Lighthizer, Canadian Foreign Affairs Minister Chrystia Freeland and Mexican Secretary


US - CBP issues additional guidance on cargo processing during Hurricane Irma and Harvey
  • Baker McKenzie
  • USA
  • September 8 2017

On September 7, 2017, U.S. Customs and Border Protection (CBP) issued CSMS 17-000543 providing additional guidance on cargo processing during


US - Identifying trading partners under the Drug Supply Chain Security Act
  • Baker McKenzie
  • USA
  • August 24 2017

On August 24, 2017, the U.S. Food and Drug Administration (FDA) published in the Federal Register a notice Docket No. FDA-2017-D-1956 announcing the


US - FDA’s Import Trade Auxiliary Communications System (ITACS)
  • Baker McKenzie
  • USA
  • August 22 2017

The U.S. Food and Drug Administration (FDA) announced that it is planning to release its new ITACS Account Management functionality on Monday


FDA Issues Digital Health Innovation Action Plan
  • Baker McKenzie
  • USA
  • August 1 2017

On 27 July 2017, the US Food and Drug Administration (FDA) issued its Digital Health Innovation Action Plan (Plan) (here) which outlines the Agency's


US FDA - no longer "not" cosmetics?
  • Baker McKenzie
  • USA
  • July 19 2017

The Personal Care Products Safety Act bill (PCPS), originally introduced in 2015, has been re-introduced with bipartisan support. Notwithstanding


US - FDA related low value shipments updated
  • Baker McKenzie
  • USA
  • July 11 2017

The US Food & Drug Administration (FDA or the Agency) is updating previously issued information to clarify FDA expectations for the submission of