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Current trends in the FDA's enforcement of GMP requirements
  • Jones Day
  • USA
  • March 15 2013

Drugs and devices are "adulterated," as that term is used in the Food, Drug, and Cosmetic Act, if the drugs and devices are contaminated, impure, or


Food, dietary supplement & cosmetics regulatory update, volume II, issue 12
  • Jones Day
  • USA, European Union
  • June 11 2015

FDA issued a final rule last week, called the Veterinary Feed Directive ("VFD"), that reduces the amount of antibiotics used in animal production. As


Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. III, Issue 7
  • Jones Day
  • USA, Canada, China, European Union
  • May 9 2016

On May 4, 2016, FDA announced that both the U.S. and Canada have recognized each other's food safety systems as comparable to each other. This is the


Food, dietary supplement & cosmetics regulatory update, vol. II, issue 2
  • Jones Day
  • USA
  • January 22 2015

Earlier this month, FDA published the draft Environmental Impact Statement ("Draft EIS") for the Proposed Rule for Standards for Growing, Harvesting


Food, dietary supplement & cosmetics regulatory update Volume II, Issue 20
  • Jones Day
  • USA, European Union
  • November 13 2015

As previously published in our Jones Day Update, the United States recently closed the Trans-Pacific Partnership ("TPP") agreement with 11 other


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."


Food, dietary supplement & cosmetics regulatory update Volume II, Issue 21
  • Jones Day
  • USA
  • December 3 2015

On November 13, 2015, FDA published three major Food Safety Modernization Act ("FSMA") rules. These final rules require food importers and producers


Food, dietary supplement & cosmetics regulatory update, vol. II, issue 6
  • Jones Day
  • USA
  • March 18 2015

During a Senate budget hearing last week, FDA Commissioner Margaret Hamburg stressed the need for a total of $1.5B for food safety and nutrition for


Food, Dietary Supplement & Cosmetics Regulatory Update Volume III, Issue 3
  • Jones Day
  • USA
  • February 11 2016

After more than six years of negotiations, last week the United States and 11 other Pacific Rim nations (Australia, Brunei, Canada, Chile, Japan


Food, dietary supplement & cosmetics regulatory update, vol. ii, issue 7
  • Jones Day
  • USA, European Union
  • April 8 2015

FDA recently announced a public meeting on its implementation strategy for the Food Safety Modernization Act ("FSMA"), titled "FDA Food Safety