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Cannabis Legal & Regulatory Update - October-December 2018
  • Allen & Overy LLP
  • Global
  • January 14 2019

On 17 October 2018, Canada became the first country in the G7 and the second country in the world (after Urugua) to legalise the marketing of


FDA to Overhaul Medical Device Approval Process
  • Epstein Becker Green
  • USA
  • December 11 2018

On November 26, 2018, the U.S. Food and Drug Administration (“FDA”) announced the process for clearing most medical devices for marketing is being


FDA Issues New Final and Draft Guidance Documents on Nutrition Facts Label and Serving Size Rules
  • Keller and Heckman LLP
  • USA
  • November 5 2018

In May 2016, FDA issued final rules changing the Nutrition Facts label for packaged foods and also updating regulations on serving sizes to - among


CMS considers linking Medicare drug payment rates to international prices
  • Hogan Lovells
  • USA
  • October 30 2018

On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an Advance Notice of Proposed Rulemaking (ANPRM) describing a potential


FDA Issues New Guidance on Biosimilar Development under the BPCIA
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • October 29 2018

Last month, the FDA released four new guidance documents providing insight on the FDA’s interpretation of provisions of the Biologics Price


FDA Draft Guidance on Verification Systems Under the Drug Supply Chain Security Act for Prescription Drugs
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • October 29 2018

On October 24, 2018, FDA issued draft guidance on verification systems under the Drug Supply Chain Security Act (DSCSA) for prescription drugs. FDA


FDA schedules public hearing on solutions to drug shortages
  • Hogan Lovells
  • USA
  • October 8 2018

FDA schedules public hearing on solutions to drug shortages October 08, 2018 The U.S. Food and Drug Administration (FDA) has announced it will hold a


Health Canada invites public comments on new post-market reporting regulations
  • Gowling WLG
  • USA, Canada
  • August 9 2018

The medical device industry in America and perceived shortcomings in the US Food and Drug Administration's ("FDA") approval process have recently come


PTAB Upholds GILENYA Method of Treatment Patent, Prompting New ANDA Litigation
  • Jones Day
  • USA
  • July 30 2018

In Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 (Jul. 11, 2018), the PTAB held that the claims of U.S. Patent No. 9,187,405 were not


A Petitioner’s Dilemma in Post-Grant Reviews
  • K&L Gates
  • USA
  • June 5 2018

Post-grant reviews ("PGRs") can only be filed within a nine-month window starting from the issuance of the patent, but standing to appeal to the