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FDA Releases First in Series of Draft Guidances Regarding Mitigation Strategies to Protect Against Intentional Adulteration
  • Kelley Drye & Warren LLP
  • USA
  • July 2 2018

On June 20, 2018, the Food and Drug Administration (“FDA”) released draft guidance for companies required to comply with the FDA’s final rule


FDA Releases Guidance Regarding Strategies to Protect Against Food Adulteration
  • Kelley Drye & Warren LLP
  • USA
  • July 2 2018

On June 20, 2018, the FDA released draft guidance regarding the FDA’s Mitigation Strategies to Protect Food Against Intentional Adulteration Rule (IA


USDA and FDA Announce Proposed Bioengineered Disclosure Rules and Labeling Rule Compliance Date Changes
  • Kelley Drye & Warren LLP
  • USA
  • May 15 2018

Both the USDA and the FDA recently released updates to food labeling regulations that will significantly affect food manufacturers. On Friday, May 4


FDA: Still in Action on Food Safety Violations
  • Kelley Drye & Warren LLP
  • USA
  • June 23 2017

Vigorous food safety enforcement for basic violations continues under the leadership of new FDA Commissioner, Dr. Scott Gottlieb. On June 20, on the


FDA Continues FSMA Implementation, Finalizes Guidance on Voluntary Qualified Importer Program to Expedite Food Imports
  • Kelley Drye & Warren LLP
  • USA
  • November 18 2016

The Food & Drug Administration (FDA) released last week a final version of its guidance for industry on the Voluntary Qualified Importer Program


FDA proposes gluten-free labeling standards for fermented and hydrolyzed foods
  • Kelley Drye & Warren LLP
  • USA
  • November 23 2015

On November 18, 2015, the FDA issued a proposed rule to set standards for making a "gluten-free" claim for foods that are fermented, hydrolyzed, or


FDA partially stays controversial policy of requiring INDs for clinical studies evaluating food, dietary supplements and cosmetics
  • Kelley Drye & Warren LLP
  • USA
  • November 10 2015

On Friday, October 30, 2015, FDA issued a Federal Register Notice announcing a partial stay of the agency's controversial Final IND Guidance entitled


Sunscreen Innovation Act changes FDA review process for more than just OTC sunscreens
  • Kelley Drye & Warren LLP
  • USA
  • December 10 2014

On November 26, 2014, the President signed into law the "Sunscreen Innovation Act." The Act is primarily intended expedite the Food and Drug


FDA holds October workshop to catalyze collaborative approach to healthcare and medical device cybersecurity; seeks comment from interested parties
  • Kelley Drye & Warren LLP
  • USA
  • October 30 2014

On October 21-22, 2014, the Food and Drug Administration (FDA) hosted a public workshop on health-related cybersecurity issues. The workshop was


FDA seeks to catalyze collaborative approaches for medical device and healthcare cybersecurity; announces October workshop and comment deadlines
  • Kelley Drye & Warren LLP
  • USA
  • September 29 2014

On September 23, 2014, the Food and Drug Administration (FDA) released a notice of public workshop and Request for Comments on health-related