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Full-Text Articles in Food and Drug Law
Memorandum Re: Health Canada's 'Draft Guidance' On Section 21.1(3)(C) Of The Food And Drugs Act, Matthew Herder, Trudo Lemmens
Memorandum Re: Health Canada's 'Draft Guidance' On Section 21.1(3)(C) Of The Food And Drugs Act, Matthew Herder, Trudo Lemmens
Reports & Public Policy Documents
In 2014 Parliament enacted a number of amendments to the Food and Drugs Act, R.S.C. 1985, c. F-27 [hereinafter the “F&D Act”]. Known as “Vanessa’s Law,” these amendments were intended to enhance the regulation of pharmaceutical drugs and thereby protect Canadians from harm by giving the regulator, Health Canada, new powers to, inter alia, recall drugs, require active post-market surveillance, and improve the transparency of information around pharmaceutical drugs. Vanessa’s Law explicitly recognized that “new measures are required to further protect Canadians from the risks related to drugs and medical devices.” (emphasis added) (Bill C-17, An Act to Amend the …
The Law Of 180-Day Exclusivity, Erika Lietzan, Julia Post
The Law Of 180-Day Exclusivity, Erika Lietzan, Julia Post
Faculty Publications
In 1984, Congress created a statutory pathway for approval of generic drug applications and included an incentive for generic applicants to challenge the patents claiming the reference drugs on which they based their applications. The first generic applicant to file an ANDA with a patent challenge is eligible for 180 days of generic market exclusivity. This article is the fourth in a series of articles describing the resulting body of law, as interpreted and applied by FDA (in regulations, guidances, citizen petition responses, and individual decisions awarding and denying exclusivity) and the courts. The heart of the article is section …