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FDA's Evolving Regulation of Artificial Intelligence in Digital Health Products
  • Jones Day
  • USA
  • January 22 2018

FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided


Food, Dietary Supplement & Cosmetics Update Vol. V, Issue 1
  • Jones Day
  • USA, European Union
  • January 12 2018

On January 4, 2018, the U.S. Food and Drug Administration ("FDA") issued a guidance announcing that it does not intend to enforce certain provisions


False Claims Act's "Rigorous" Materiality Standard Enforced by Second Circuit
  • Jones Day
  • USA
  • January 11 2018

A decision by the U.S. Court of Appeals for the Second Circuit reinforces the growing body of case law regarding the strict materiality requirements


Food, Dietary Supplement & Cosmetics Update Vol. IV, Issue 7
  • Jones Day
  • USA, European Union
  • November 16 2017

The USDA Inspector General ("IG") reviewed the Agricultural Marketing Service's ("AMS") process used in determining whether exporting countries'


PTAB Grants Rare Rehearing Due To Insufficient Evidence Of Obviousness
  • Jones Day
  • USA
  • September 21 2017

In Coalition For Affordable Drugs VI, LLC v. Celgene Corp. (2015-01096, -01102, -01103), the PTAB granted Patent Owner Celgene's request for


Global Privacy & Cybersecurity Update Vol. 15
  • Jones Day
  • USA, European Union, Global
  • September 13 2017

On June 19, the Federal Trade Commission ("FTC") submitted comments to a working group organized by the Department of Commerce's National


Food, Dietary Supplement & Cosmetics Update Vol. IV, Issue 6
  • Jones Day
  • USA
  • September 9 2017

On September 13, 2017, the Food and Drug Administration issued a proposed rule to extend, for covered produce other than sprouts, the dates for


FDA Establishes Electronic Privacy, Security, and Reliability Criteria for Clinical Trial Records
  • Jones Day
  • USA
  • July 28 2017

Technological advances and the growing use of electronic records and tools potentially raise privacy and security concerns in connection with certain


Food, Dietary Supplement & Cosmetics Update Vol. IV, Issue 5
  • Jones Day
  • USA, European Union
  • June 30 2017

On June 13, 2017, FDA delayed the compliance date for the Nutrition Facts and Supplement Facts Label and Serving Size final rules, providing


Supreme Court: Biosimilar Applicants May Provide Commercial Marketing Notice Before FDA Approval
  • Jones Day
  • USA
  • June 21 2017

Intended to provide a faster route to approval for generic biologics, the Biologics Price Competition and Innovation Act, was the basis for a