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FDA Draft Guidance Regarding Inclusion of Pregnant Women in Clinical Trials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On April 3, 2018, FDA published long awaited draft guidance entitled "Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical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


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'


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


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


FDA Reorganizes ORA Staff, Pharmaceutical & Medical Device Update, Vol. IV, Issue III
  • Jones Day
  • USA
  • June 4 2017

On May 15, 2017, the Food and Drug Administration's ("FDA" or "Agency") Office of Regulatory Affairs ("ORA") began implementing a "Program Alignment


United States and Australia: Comparable Food Safety Systems
  • Jones Day
  • USA, Australia
  • May 18 2017

On April 19, 2017, FDA announced that both the United States and Australia have recognized each other's food safety systems as comparable to each


FDA Postpones Menu Labeling Rule Again
  • Jones Day
  • USA
  • May 18 2017

On May 1, 2017, FDA announced it was extending the compliance date for the menu labeling final rule from May 5, 2017, to May 7, 2018. The rule


FDA Issues Further Guidance Related to FSVP
  • Jones Day
  • USA
  • May 18 2017

On May 11, 2017, FDA announced a new updated fact sheet and a guidance related to the use of a Unique Facility Identifier that is acceptable under the