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FDA Proposes New Class II Device Marketing Pathway
  • Arent Fox LLP
  • USA
  • April 17 2018

The Expanded Abbreviated 510(k) Program could offer a quicker path to market for class II devices, with the potential for clearance decisions to


In Rare Move, FDA Debars Company from Importing Food
  • Arent Fox LLP
  • USA
  • March 15 2018

For the first time in recent history, the Food and Drug Administration has debarred a foreign firm from importing food into the United States. The


FDA Authorizes First Direct-to-Consumer Genetic Test for Cancer
  • Arent Fox LLP
  • USA
  • March 14 2018

On March 6, 2018, the US Food and Drug Administration issued an authorization letter to 23andMe, Inc. that permits marketing of the company’s genetic


FDA Ramps Up Transparency Initiative but Still Exploring Whether to Include CR Letters
  • Arent Fox LLP
  • USA
  • January 24 2018

On January 16, 2018, FDA Commissioner Scott Gottlieb, M.D., delivered a presentation, “Fostering Transparency to Improve Public Health” to the John


FDA Taps the Brakes on Certain Aspects of FSMA Compliance
  • Arent Fox LLP
  • USA
  • January 17 2018

Recently, the FDA announced that it does not intend to enforce certain provisions in four of the rules that implement the FDA Food Safety


Rare Pediatric Disease Clinical Trials Get New Lift from EMA-Inspired Gaucher Model
  • Arent Fox LLP
  • USA
  • December 13 2017

On December 6, 2017, FDA announced a new approach for pediatric disease drug development that the Agency believes will reduce the number of patients


FDA Issues Comprehensive Tissue Product Regulatory Framework
  • Arent Fox LLP
  • USA
  • November 21 2017

On November 16, 2017, FDA announced a comprehensive regenerative medicine policy framework to provide additional clarity regarding existing and future


Companies Marketing CBD Products Be Warned: FDA Is Watching
  • Arent Fox LLP
  • USA
  • November 20 2017

The US Food and Drug Administration recently issued warning letters to four companies - Stanley Brothers Social Enterprises LLC, Greenroads Health


FTC Holds Public Workshop to Consider If Hatch-Waxman Is Working for Prescription Drug Competition
  • Arent Fox LLP
  • USA
  • November 13 2017

On November 8, 2017, the Federal Trade Commission held a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply


FDA Announces “New” Framework to Regulate Stem Cell Therapies and Regenerative Medicine
  • Arent Fox LLP
  • USA
  • September 8 2017

Last week, FDA Commissioner Gottlieb issued a statement describing the Agency’s “new” policy for regulating stem cell therapies and regenerative