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Results: 1-10 of 175

OIG Report Highlights Impact of Improper Drug Classification
  • Arent Fox LLP
  • USA
  • January 12 2018

In late December 2017, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released the findings of a report


What Could Happen to Imports If Government Shuts Down: 2017 Version
  • Arent Fox LLP
  • USA
  • December 15 2017

Based on recent activity in Congress, the possibility of a shutdown of US federal government activities for at least a brief period of time is looming


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


California Passes Drug Transparency Law with Onerous Reporting Requirements for Manufacturers
  • Arent Fox LLP
  • USA
  • October 20 2017

Following in the steps of Maryland and Nevada, California just adopted a comprehensive drug pricing transparency law that will have a significant


FDA Requires Pharma Companies to Certify Drug Listing Info
  • Arent Fox LLP
  • USA
  • October 6 2017

In August 2016, the Food and Drug Administration issued a final rule to update and clarify the agency’s drug registration and listing regulations. The


CBP Offers Guidance to the Trade Community on Cargo Processing During Hurricanes Irma and Harvey
  • Arent Fox LLP
  • USA
  • September 14 2017

US Customs and Border Protection issued notices reminding the importing community of diversion procedures for cargo destined to US ports closed due to


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