Medical Device Legal News with Sam Bernstein: Episode 11
On June 10, 2025, Health Canada launched a consultation on its Draft Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs which includes numerous proposed revisions to the current guidance...more
Introduction Le 21 février 2024, la Banque du Canada (la « Banque ») a publié des lignes directrices provisoires sur la supervision des paiements de détail (les « lignes directrices ») en vertu de la Loi sur les activités...more
Introduction - On February 21, 2024, the Bank of Canada (BOC) released draft supervisory guidelines (Guidelines) on the Retail Payments Activities Act (RPAA), providing insight into how they will be interpreting the...more
The Autorité des marchés financiers (“AMF”) recently released a draft version of its Incentive Management Guideline (“Draft Guideline”), which applies to Québec-regulated insurers, financial services cooperatives, trust...more
On March 12, 2021, Health Canada released for consultation its new Draft Guidance Document on Electronic media in prescription drug labelling. The draft Guidance sets out Health Canada’s expectations for drug manufacturers...more
The PMPRB has extended the deadline for comments on the revised draft Guidelines to August 4, 2020. ...more
As previously reported, the Patented Medicine Prices Review Board (PMPRB) recently released draft Guidelines operationalizing the amended Patented Medicines Regulations for consultation. The consultation period has been...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
In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more
On November 21, 2019, the Patented Medicine Prices Review Board (PMPRB) released draft Guidelines operationalizing the recent amendments to the Patented Medicines Regulations for consultation...more
• FDA issues a Proposed Rule to allow states and other entities to import certain prescription drugs from Canada. • In addition, FDA issues draft guidance for industry to explain how drug manufacturers can import their own...more
On November 21, 2019, the Patented Medicines Prices Review Board (“PMPRB”) released draft new Guidelines for consultation, together with a backgrounder. The new Guidelines are intended to operationalize the amended Patented...more
Federal Court of Appeal requires PMPRB to re-determine whether patent ‘pertains to’ Galderma’s DIFFERIN - On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB...more
On May 3, 2019, two sets of proposed amendments to the Food and Drug Regulations were published: The proposed amendments contain provisions which would streamline the process for providing access to unauthorized drugs for...more
Health Canada released proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (“proposed Regulations”) on March 30, 2019. Comments may be submitted until June 8, 2019....more
As previously reported, the amended Patented Medicines (Notice of Compliance) Regulations (“Regulations”) came into force on September 21, 2017, heralding significant changes to the landscape for pharmaceutical companies in...more
On August 20, 2015, the Office of the Superintendent of Financial Institutions (OSFI) released Draft Guideline E-21: Operational Risk Management (Draft Guideline) for comments. With the Draft Guideline, OSFI aims to provide a...more