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Results: 1-10 of 107

FDA Issues First Installment of Guidance on ‘Mitigation Strategies to Protect Food Against Intentional Adulteration’ Rule
  • Barnes & Thornburg LLP
  • USA
  • July 3 2018

As part of its implementation of the Food Safety Modernization Act, the FDA two years ago published a final rule titled, “Mitigation Strategies to


FDA Draft Guidance Revamps Assessment of Multiple Function Devices
  • Barnes & Thornburg LLP
  • USA
  • May 8 2018

The FDA recently issued a draft guidance titled, "Multiple Function Device Products: Policy and Considerations," which seeks to clarify FDA's policy


Food, Drug and Device Law Alert - FDA Makes Revisions to Two Medical Device Application Process Documents
  • Barnes & Thornburg LLP
  • USA
  • February 5 2018

The FDA recently issued two revised final medical device guidance documents titled, “Refuse to Accept Policy for 510(k)s” and“Acceptance and Filing


Food, Drug and Device Law Alert - FDA Publishes List of Class I Devices Exempted From 510(k) Process
  • Barnes & Thornburg LLP
  • USA
  • April 13 2017

As previously reported, Congress passed and then-President Obama signed the 21st Century Cures Act last December to implement a number of FDA reforms


Food, Drug and Device Law Alert - Major FDA Reform Bill Becomes Law: Medical Device Overview
  • Barnes & Thornburg LLP
  • USA
  • December 13 2016

President Obama recently signed the 996-page 21st Century Cures Act to implement a variety of reforms to the Food and Drug Administration's (FDA


Food, Drug and Device Law Alert - FDA Issues Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food
  • Barnes & Thornburg LLP
  • USA
  • August 29 2016

As regular readers of these alerts know, almost one year ago the Food and Drug Administration (FDA) released its final rule entitled, “Current Good


Is It Juice or Sugar? Use of ‘Evaporated Cane Juice’ in Food Labels Criticized by FDA
  • Barnes & Thornburg LLP
  • USA
  • June 3 2016

The Food and Drug Administration (FDA) recently issued a final guidance for food manufacturers on the use of the term "evaporated cane juice" on food


FDA issues final rule to protect against intentional adulteration of food
  • Barnes & Thornburg LLP
  • USA
  • June 2 2016

The Food and Drug Administration (FDA) recently issued the last of the major rules implementing the Food Safety Modernization Act, titled "Focused


FDA serves up new Nutrition Facts label
  • Barnes & Thornburg LLP
  • USA
  • June 1 2016

The Food and Drug Administration (FDA) recently issued a final rule to implement the new Nutrition Facts label for packaged foods. According to the


FDA addresses postmarket surveillance for medical devices in final guidance
  • Barnes & Thornburg LLP
  • USA
  • May 31 2016

The Food and Drug Administration (FDA) recently issued a final guidance addressing postmarket surveillance for medical devices. The FDA is authorized