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NDAANDA Holders Must Affirmatively Submit Data to FDA or Risk Losing Products’ Active Listing in The Orange Book
  • Mintz Levin
  • USA
  • January 18 2018

Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have

Post-market medical devices, cybersecurity, and the U.S. FDA’s growing concerns
  • Hogan Lovells
  • USA
  • January 17 2018

From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations

Life Sciences & Antitrust: Cases to Watch in 2018
  • Paul Hastings LLP
  • USA
  • January 17 2018

The intersection of complex drug competition frameworks and the antitrust laws continues to grow. With increased collaboration between the Food and

FDA Releases 2018 Roadmap: Focus On Digital Health Continues
  • Kelley Drye & Warren LLP
  • USA
  • January 16 2018

Last week, FDA released a document outlining its policy priorities for the coming year. “Healthy Innovation, Safer Families: FDA’s 2018 Strategic

Hazardous Waste Management Pitfalls for Vapor and E-Liquid Product Manufacturers and Retailers
  • Keller and Heckman LLP
  • USA
  • January 16 2018

Beyond the Food and Drug Administration (FDA) and Tobacco Control Act requirements that now apply to deemed tobacco products, manufacturers and

Washington Healthcare Update - Jan 16, 2018
  • McGuireWoods LLP
  • USA
  • January 16 2018

On Jan. 10, the House Republican Steering Committee recommended Rep. Steve Womack (R-AR) to chair the House Budget Committee, replacing Rep. Diane

3D Printing Meets Medical Devices: FDA Weighs In On Additive Manufacturing
  • Morrison & Foerster LLP
  • USA
  • January 16 2018

In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices. The

FDA Proposes to Delay Off-Label “Intended Use” Rule
  • Reed Smith LLP
  • USA
  • January 16 2018

Perhaps you have heard that elections have consequences. That is true not only for high-profile issues that hog the headlines on CNN and Fox News, but

Celltrion and Teva File Declaratory Judgment Action Against Thirty-Eight Herceptin-related Patents
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • January 15 2018

On January 11, 2018, Celltrion, Inc., Celltrion Healthcare, Co. Ltd. (collectively “Celltrion”), Teva Pharmaceuticals International GmbH, and Teva

Food, Dietary Supplement & Cosmetics Update Vol. V, Issue 1
  • Jones Day
  • USA, European Union
  • January 12 2018

On January 4, 2018, the U.S. Food and Drug Administration ("FDA") issued a guidance announcing that it does not intend to enforce certain provisions