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Results:1-10 of 245

What Digital Health Innovators Should Know about the FDA Approval Process
  • Jones Day
  • USA
  • November 6 2018

Jones Day partner Ann Hollenbeck shares an informative conversation with associate Ian Pearson, who was a lead in the area of digital health at the U


Pharmaceutical Company Agrees to $625 Million False Claims Act Settlement
  • Jones Day
  • USA
  • October 17 2018

The civil settlement is one the largest FCA settlements in recent years. The Department of Justice ("DOJ") recently announced that it agreed with


PTAB Upholds GILENYA Method of Treatment Patent, Prompting New ANDA Litigation
  • Jones Day
  • USA
  • July 30 2018

In Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 (Jul. 11, 2018), the PTAB held that the claims of U.S. Patent No. 9,187,405 were not


FDA Draft Guidance Regarding Inclusion of Pregnant Women in Clinical Trials
  • Jones Day
  • USA
  • June 28 2018

On April 3, 2018, FDA published long awaited draft guidance entitled "Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical


FDA Releases Software Precertification Working Model
  • Jones Day
  • USA
  • May 29 2018

On April 26, 2018, the U.S. Food and Drug Administration ("FDA") released an initial working model for its Software Precertification ("Pre-Cert")


FDA Permits Marketing of First Autonomous Artificial Intelligence-Based Medical Device
  • Jones Day
  • USA
  • May 23 2018

On April 11, 2018, the U.S. Food and Drug Administration ("FDA") permitted marketing of the first device to use artificial intelligence ("AI")


ITC Institutes Investigation Based on Allegation of Drug Sales Without FDA Approval
  • Jones Day
  • USA
  • May 17 2018

Normally, it is the FDA that monitors the improper distribution of drugs. But, as it turns out, the International Trade Commission ("ITC") might be


Tribal Sovereign Immunity Doctrine Does Not Insulate Tribes From Board Actions
  • Jones Day
  • USA
  • February 27 2018

In a case of first impression, the PTAB recently decided that the doctrine of tribal sovereign immunity does not apply to inter partes review


DOJ Limits the Use of Agencies' Guidance Documents in Civil Enforcement Actions
  • Jones Day
  • USA
  • January 31 2018

The Department of Justice ("DOJ") recently issued a memorandum limiting the ability of its litigators to use agency guidance documents in civil


Artificial Intelligence and Health CareKey Regulatory Considerations for U.S. Operations
  • Jones Day
  • USA
  • January 26 2018

Artificial intelligence is being used in innovative ways in the health care industry to drive down costs and improve clinical outcomes. The health