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Food, Dietary Supplement & Cosmetics Regulatory Update Vol. III, Issue 16
  • Jones Day
  • USA
  • December 21 2016

FDA issued an interim final rule amending the regulation that governs when a food label may make a health claim on the relationship between dietary

Food, Dietary Supplement & Cosmetics Regulatory Update Vol. III, Issue 13
  • Jones Day
  • USA, OECD, European Union
  • October 6 2016

On September 28, 2016,FDA announced it has started a public process to redefine the "healthy" nutrient content claim for food labeling. On December 1

Food, dietary supplement & cosmetics regulatory update, Issue 11
  • Jones Day
  • USA, Canada, China
  • August 8 2014

Last week, a divided federal appeals court ruled that FDA cannot be forced to ban antibiotics in food-producing healthy livestock. Thedecision comes

Court injunction will require the FDA to accelerate the roll-out of FSMA regulations
  • Jones Day
  • USA
  • April 25 2013

The Food Safety Modernization Act, known as "FSMA," calls upon the Food and Drug Administration ("FDA") to promulgate extensive new regulations on a

The safe harbor for FDA submissions expands: did the Federal Circuit reverse course?
  • Jones Day
  • USA
  • August 29 2012

Section 271(e)(1) of the patent code, known as the "safe harbor" provision, immunizes from infringement suits various acts that are undertaken in order to submit information to the Food and Drug Administration ("FDA").

Do compounding pharmacies "live in sin"? The FDA's assertion of enforcement authority over pharmacy compounding, and two courts' efforts to bless the practice
  • Jones Day
  • USA
  • November 1 2011

Pharmacy compounding, as the Food and Drug Administration ("FDA") explains, "is an age-old practice in which pharmacists combine ingredients to create unique medications that meet specific needs of individual patients."

Certain post-approval activities to support submissions to the FDA are now subject to claims of patent infringement
  • Jones Day
  • USA
  • September 20 2011

On August 31, the Federal Circuit significantly restricted the scope of the "safe harbor" provision of 35 U.S.C. 271(e)(1), which immunizes the use of patented inventions in connection with regulatory submissions to the Food and Drug Administration ("FDA").