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Results:1-10 of 91

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


Cybersecurity and medical devices: Electronic medical data increases product liability risk for medical device manufacturers
  • Gowling WLG
  • USA, Canada
  • May 3 2016

The value of stolen personal health information is ten to twenty times greater than a stolen credit card number.1 As the health-care industry


A balancing act: innovation and the regulatory-approval exemption
  • Gowling WLG
  • Canada
  • April 22 2013

In the pharmaceutical sector, patent systems are concerned with balancing the interests of innovator drug companies, the public and generic


Natural Health Products Directorate proposes changes to the site licensing model, GMP standards and product licence applications
  • Gowling WLG
  • Canada
  • October 31 2011

The Natural Health Products Directorate (NHPD) is seeking input regarding proposed changes to the Natural Health Product Regulations, the current site licensing model, the Good Manufacturing Practices (GMP) standards, and the information required for a natural health product (NHP) licence application.


Apotex loses the war in Canada and the battle in England: UK courts rely on Canadian decision to find Apotex acting unlawfully in cCnada has consequences in eErope
  • Gowling WLG
  • United Kingdom, Canada
  • October 13 2011

Servier developed perindopril erbumine (“perindopril”) which is a successful long lasting ACE inhibitor sold under the trade-mark COVERSYL.


Data protection in Canada: too much? Too little?
  • Gowling WLG
  • Canada
  • June 28 2011

Prior to the enactment in 2006 of the amendments to section C.08.004.1 of the Food and Drugs Regulations (Data Protection Regulations), Canada did not have an effective regime of data protection exclusivity.


Eli Lilly Canada Inc. v. Hospira Healthcare Ccorporation - interlocutory order, motion to amend statement of claim (gemcitabine)
  • Gowling WLG
  • Canada
  • June 28 2011

This is an appeal of an Order whereby Madam Prothonotary Tabib allowed Lilly to amend its Statement of Claim after the Statement of Defence had been served but prior to examinations for discovery.


Two amendments to pharma legislation come into force
  • Gowling WLG
  • Canada
  • April 14 2011

The Amendments to The Food and Drug Regulations (1319- New Drugs For Extraordinary Use) came into force on March 25, 2011.


Apotex Inc. v. H. Lundbeck AS (2011 FC 88), citalopram, T-575-04, January 26, 2011
  • Gowling WLG
  • Canada
  • March 15 2011

In an action for patent infringement and under s. 8 of the Patented Medicines (Notice of Compliance) Regulations regarding citalopram, Prothonotary Tabib granted Lundeck’s request for letters rogatory with respect of Matrix Laboratories Ltd.


Board follows guidelines in Penlac decision
  • Gowling WLG
  • Canada
  • February 7 2011

On February 3, 2011, the Patented Medicine Prices Review Board (the Board) released its decision dated January 31, 2011, regarding Penlac, a drug manufactured by sanofi-aventis.