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FDA Seeks to Provide Greater Insight on Off-Label Promotions of Pharmaceuticals
  • Womble Bond Dickinson (US) LLP
  • USA
  • September 25 2018

The US Food & Drug Administration (FDA) serves as the gatekeeper between pharmaceutical companies and the public they serve, including governing how


CMS Allows Medicare Part D Indication-Based Formulary Design
  • Holland & Knight LLP
  • USA
  • August 30 2018

The Centers for Medicare and Medicaid Services (CMS) has just announced a significant shift in Medicare Part D formulary design to allow Part D


Life Sciences: product regulation and liability in China
  • Ropes & Gray LLP
  • China, Global
  • July 31 2018

A structured guide to product regulation and liability laws in China


Washington Healthcare Update - Jul 16, 2018
  • McGuireWoods LLP
  • USA
  • July 16 2018

In a two-day markup, the House Ways and Means Committee cleared a number of measures related to health savings accounts and a measure that would


Life sciences: product regulation and liability in Thailand
  • Baker McKenzie
  • Thailand, Global
  • July 11 2018

A structured guide to product regulation and liability laws in Thailand


Requirements, Benefits, and Possible Consequences of Listing Patents in FDA’s Orange Book
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • July 3 2018

The Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act) amended patent law and drug law to facilitate


Another Step Forward - FDA Issues Two Final Guidance Documents on Communicating Medical Product Information
  • Baker McKenzie
  • USA
  • June 21 2018

On 12 June 2018, the Food and Drug Administration (FDA) issued two final guidance documents providing feedback on acceptable means for drug and device


Pharmaceuticals and Brexit: Keeping the industry healthy
  • Linklaters LLP
  • United Kingdom, European Union
  • June 19 2018

It is estimated that each month 37 million packs of medicines are supplied from European countries to the UK with 45 million heading in the other


Connecticut and Maine Become the Latest States to Adopt New Drug Pricing Transparency Laws
  • Arent Fox LLP
  • USA
  • June 6 2018

Connecticut and Maine recently joined the increasing number of states to enact drug price transparency laws. Maine’s drug price transparency law (the


Never-Ending Liability Under Novartis
  • Wilson Elser
  • USA
  • May 29 2018

The Evolution of Innovator Liability for Pharmaceutical Manufacturers Brand-name drug manufacturers are not unfamiliar with the concept of Innovator