While the term “microplastics” has been making waves in certain circles, especially in the context of seafood and water, broader public unease about their presence in our foods is ramping up at a concerning pace. A recently...more
The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more
The Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) was signed into law alongside other reforms to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) on December 29, 2022, as part of a broader consolidated...more
The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule...more
The Federal Government has published the following proposed amending regulations in Part 1 of the Canada Gazette: - Regulations Amending the Food and Drug Regulations (Exports and Transhipments of Drugs): The amendments...more
Don't rely on it too much -- yet. We recently got our first federal court decision addressing whether an employer had the right to require employees to be vaccinated for COVID-19. The court's answer was yes... ...more
On September 28, 2020, the Regulations Amending Certain Regulations Made under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) (Regulations) came into force. Health Canada subsequently published a Notice,...more
UPDATE: The Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19: Notice was made on May 3, 2021 (see Notice here) and repeals the Interim Order respecting clinical trials for...more
Spanning 5525 miles, the United States-Canada border is the longest border between any two countries. U.S. goods and services trade with Canada totaled an estimated $718.5 billion in 2018, possibly the largest bilateral trade...more
This article was last updated on July 10, 2020. In view of COVID-19, we have compiled a list of important updates as it relates to the pandemic and its impact on Life Sciences. We will continue to update this page as new...more
Update: On November 2, 2021, the Federal Court of Appeal dismissed C-RNA’s appeal from McHaffie J.’s decision: Canada RNA Biochemical Inc v Canada (Minister of Health), 2021 FCA 213. On June 4, 2020 the Federal Court...more
This article was last updated on June 26, 2020. In view of COVID-19, we have compiled a list of important updates as it relates to the pandemic and its impact on Life Sciences. We will continue to update this page as new...more
UPDATE: The Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 was made on March 1, 2021 and repeals and replaces the Interim Order Respecting Drugs, Medical...more
In view of COVID-19, as of March 31, 2020: Patent, trademark and industrial design deadlines that fall due between March 16 - April 30 are extended until May 1 (see here and FAQs regarding the initial extension)....more
In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more
The U.S. Federal Trade Commission (FTC) announced last week it had sent warning letters to three companies advertising cannabidiol products with unproven claims that their products were able to treat or cure serious ailments...more
PMPRB amendments expected to come into force no earlier than Spring 2020 - On April 1, 2019, Health Canada released Forward Regulatory Plan 2019-2021: Regulations Amending the Patented Medicines Regulations. This brief...more
In the first case calling upon a court to interpret and apply Vanessa’s Law, the Federal Court has ordered Health Canada to release requested complete copies of all sections of all clinical study reports and all electronic...more
An Update on Vanessa’s Law - This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act...more
This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act (“FDA”) and granting new powers to...more