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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


Pharmaceutical & medical device regulatory update, vol. II, issue 5
  • Jones Day
  • USA
  • March 13 2015

On March 6, 2015, FDA approved Zarxio (filgrastim-sndz), the first biosimilar product to be approved in the United States under the Biologics Price


Pharmaceutical & medical device regulatory update, vol. II, issue 4
  • Jones Day
  • USA
  • February 26 2015

FDA recently issued five new documents related to drug compounding and repackaging to provide compliance information to pharmacies, physicians, and


Food, dietary supplement & cosmetics regulatory update, vol. II, issue 4
  • Jones Day
  • USA
  • February 18 2015

Dr. Margaret Hamburg has announced she will resign from her post as FDA Commissioner in March 2015, citing her long service to the agency and the


Pharmaceutical & medical device regulatory update, vol. II, issue 3
  • Jones Day
  • USA
  • February 13 2015

Dr. Margaret Hamburg has announced she will resign from her post as FDA Commissioner in March 2015, citing her long service to the Agency and 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, vol. II, issue 1
  • Jones Day
  • USA
  • January 6 2015

The White House's most recent Unified Agenda outlines several major food regulatory initiatives by FDA and USDA for the coming year. The Unified


Pharmaceutical & medical device regulatory update, issue 20
  • Jones Day
  • USA
  • December 22 2014

This week, the U.S. Department of Justice ("DOJ") indicted 14 owners and senior officials of a Massachusetts pharmacy that manufactured and


Food, dietary supplement & cosmetics regulatory update, issue 19
  • Jones Day
  • USA, European Union
  • December 10 2014

On December 1, 2014, FDA finalized two rules requiring calorie information to be listed on menus in chain restaurants and similar retail food


Food, dietary supplement & cosmetics regulatory update, issue 18
  • Jones Day
  • USA
  • November 13 2014

On November 10, 2014, FDA announced that Susan Mayne, Ph.D., an expert in nutrition, toxicology, and epidemiology, will become director of the Center