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FDA to Overhaul Medical Device Approval Process
  • Epstein Becker Green
  • USA
  • December 11 2018

On November 26, 2018, the U.S. Food and Drug Administration (“FDA”) announced the process for clearing most medical devices for marketing is being

Life sciences: product regulation and liability in Japan
  • YUASA and HARA
  • Global, Japan
  • July 11 2018

A structured guide to product regulation and liability laws in Japan

Helpful Hints - May 2018
  • Burr & Forman LLP
  • USA
  • May 15 2018

The Office of Inspector General (“OIG”) approved a proposed arrangement involving medical devicessupplies. OIG Advisory Opinion No. 18-02 concerns an

Minnesota Court Excludes Plaintiff Expert Opinions For Lack of General Acceptance
  • Reed Smith LLP
  • USA
  • March 21 2018

All of us - defense lawyers, plaintiff lawyers, and judges - tend to assume that the federal Daubert standard for admissibility of expert testimony is

Digital Health Care Investors Summit Highlights Digital Health Expansion
  • Foley & Lardner LLP
  • USA
  • December 13 2017

In early December, leading experts in digital health and telemedicine came together at the Digital Health Care Investors Summit hosted by Foley &

Healthcare Post-Mortem: Medical Industry Continues to be High-Value Target for FCA Enforcement
  • Vinson & Elkins LLP
  • USA
  • October 18 2017

Last week we gave you the bottom line of how much DOJ (and relators) recovered in FY 2017. As we promised, we are doing a series of sector-specific

U.S. embargo on Sudan permanently lifted, but some restrictions remain
  • Kelley Drye & Warren LLP
  • USA, Sudan
  • October 6 2017

Today the State Department announced that the U.S. would permanently lift the embargo on Sudan effective October 12, 2017. The decision comes 10

Capitol Hill Healthcare Update
  • Baker & Hostetler LLP
  • USA
  • June 12 2017

Senate Republicans continue intra-party discussions on changes to House-passed legislation replacing the Affordable Care Act (ACA)...

ECRI Institute Releases Guidance on How to Protect Your Medical Device Systems
  • Knobbe Martens
  • USA
  • June 9 2017

The ECRI Institute released new guidance in its article: “Ransomware Attacks: How to Protect Your Medical Device Systems” on May 18, 2017. The report

Pharmaceutical & Medical Device Regulatory Update, Vol. IV, Issue 1
  • Jones Day
  • USA
  • April 12 2017

One day before the final rule, "Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products