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The FTC Has New Enforcement Authority in the Fight against Opioid Addiction
  • Venable LLP
  • USA
  • January 8 2019

The government is serious about opioids. We can see that in the many big, headline-grabbing steps it is taking to confront the problem. We can also


Some BPCIA Clouds Begin to Clear: FDA Issues Final Plans for March 2020 “Deemed to Be a License” Provision
  • Mintz
  • USA
  • December 13 2018

In his typical forceful style on December 11, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced several big pieces


Cryoablation Competition Heats Up
  • Knobbe Martens
  • USA
  • December 11 2018

Atrial fibrillation (AF), a common heart rhythm disorder, is often treated with cardiac ablation. Cardiac ablation uses RF (heating) or cryothermal


FTC Submits Comment on FDA Guidance Aimed at Deterring Abuse of Citizen Petition Process
  • McDermott Will & Emery
  • USA
  • December 11 2018

The Federal Trade Commission (FTC) submitted comments supporting the Food and Drug Administration’s (FDA) guidance for assessing whether a


The State AG Report Weekly Update November 29, 2018
  • Cozen O'Connor
  • USA
  • November 29 2018

Bridget Hill has been appointed to serve as the Wyoming AG by Governor-elect Mark Gordon (R). Since 2013, Hill has served as Director of the Wyoming


On Prevention of Federal Fraud on the FDA Claims That Avoid Buckman
  • Reed Smith LLP
  • USA
  • October 29 2018

Private plaintiffs love to scream “fraud on the FDA”! Agency fraud is their magic potion for dissolving any FDA action that they don’t like. Just


Deterring Gaming of the Generic Drug Approval Process by the Use of Citizen Petitions
  • Cozen O'Connor
  • USA
  • October 15 2018

The FDA has recently thrown its hat into the debate between brand and generic drug manufacturers about the proper way to compete. Generics often


The Latest: FTC to Look Closely at Competition between Biologics and Biosimilars and Patent Protection Strategies of Branded Manufacturers
  • McDermott Will & Emery
  • USA
  • July 24 2018

On July 18, 2018, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb delivered a speech at The Brookings Institution in Washington, DC


FDA’s New Biosimilar Action Plan Represents the Next Step for Improving Drug Competition
  • Mintz
  • USA
  • July 19 2018

On July 18, 2018, after months of alluding to the various aspects of an upcoming “Biosimilar Action Plan” as another prong within FDA’s broader Drug


FDA Issues Guidances for Shared REMS and Waivers to Help Promote Competition and Access
  • Arent Fox LLP
  • USA
  • July 11 2018

On May 31, 2018, the FDA announced two new guidances designed to help generic drug manufacturers to obtain access to shared Risk Evaluation and