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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


FDA to increase civil money penalty amounts
  • Kelley Drye & Warren LLP
  • USA
  • February 4 2014

On February 3, 2014, FDA issued a Direct Final Rule to adjust for inflation the maximum civil money penalty ("CMP") amounts it can seek for certain


FDA targets antibacterial soaps in new proposed rule
  • Kelley Drye & Warren LLP
  • USA
  • December 17 2013

On Monday, FDA announced a new proposed rule that would amend the 1994 TFM for OTC antiseptic drug products. The change would require companies that


Bulk drug importer sues FDA for refusing entry of 20,000-kilogram API shipment
  • Kelley Drye & Warren LLP
  • USA
  • December 12 2013

Recently, H&M USA, an importer of periodic bulk shipments of active pharmaceutical ingredients (API) turned to the courts in an effort to gain relief