We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results:1-10 of 25

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


Natural health products and adverse reactions: remembering to report
  • Gowling WLG
  • Canada
  • October 31 2011

As Health Canada shifts to a proactive phase of enforcement of the Natural Health Products Regulations, it is important for natural health product (NHP) licence holders to ensure they have policies in place to monitor, assess and report adverse reactions to their products.


Fundamentals of Canadian product liability - duty to warn
  • Gowling WLG
  • Canada
  • October 4 2011

A manufacturer has a duty to warn consumers and others in the supply chain of all material risks of which it is aware, or of which it ought to be aware, resulting from ordinary use of its product.


New disclosure requirements for clinical trials
  • Gowling WLG
  • Global
  • December 3 2009

The International Federation of Pharmaceutical Manufactures and Associations (IFPMA) has released its latest Joint Position which will require member companies to disclose information on all clinical trials in patients.


Second phase of Alberta's pharmaceutical strategy aims to reduce drug costs, improve access to new drugs and expand the role of pharmacists
  • Gowling WLG
  • Canada
  • November 2 2009

On October 20, 2009, the Alberta Government released the second phase of the Alberta Pharmaceutical Strategy which indicates that the Government will reduce generic drug prices - the Government states it will reduce the price of new generic drugs from 75 percent of the brand name drug to 45 and announces that its discussions with pharmacists and pharmacies regarding the price reduction will begin this month.


U.S. patients receive greater access to unapproved medications
  • Gowling WLG
  • USA
  • August 21 2009

Seriously ill patients will have greater and easier access to unapproved medicines due to new USFDA regulations.


Canadian Pharmaceutical Technologies International v. Canada
  • Gowling WLG
  • Canada
  • May 4 2009

The Court upheld the decision of Health Canada that the applicant's product was indeed a "drug in dosage form" and thus was subject to the provisions of the Food and Drugs Act and Regulations.


Changes to UK Pharmaceutical Price Regulation Scheme now in effect
  • Gowling WLG
  • United Kingdom
  • January 19 2009

A new Pharmaceutical Price Regulation Scheme (PPRS) came into effect in the U.K. on January 1, 2009.


FDA clinical trial regulations - "Sentinal System"
  • Gowling WLG
  • USA
  • May 29 2008

On Thursday May 22, 2008, U.S. health officials announced that the FDA will implement a proactive system designed to help identify dangers associated with prescription drugs and medical devices that are currently on the market.


New regulations respecting benefits and promotional allowances in Québec
  • Gowling WLG
  • Canada
  • November 16 2007

The Government of Québec has introduced new regulations under the Act Respecting Prescription Drug Insurance governing the rebates and other benefits offered by drug manufacturers to pharmacists.