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Health Canada Food and Drug Administration (FDA)

Smart & Biggar

2024 mid-year highlights in Canadian life sciences IP and regulatory law

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In the first half of 2024, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to June and...more

Dechert LLP

Mass Tort Implications of FDA’s First of its Kind State Drug Importation Program

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For the first time, FDA approved a proposal that allows for the importation of Canadian-approved pharmaceuticals into the U.S., the first program of its kind to allow a state’s importation of pharmaceuticals approved by a...more

Quarles & Brady LLP

FDA Approves Florida’s Section 804 Importation Program for Importation of Canadian Pharmaceuticals

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On January 5, 2024 the Food and Drug Administration (FDA) issued its approval of the State of Florida’s proposal to import certain prescription drugs from Canada under the Section 804 Importation Program (SIP). This approval...more

Smart & Biggar

Medical Devices updates: Annual performance report, new guiding principles for PCCPs for machine learning-enabled medical devices,...

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Medical Devices Directorate Performance Annual Report - In September 2023, Health Canada published the Medical Devices Directorate Performance Annual Report for April 1, 2022, through March 31, 2023. The report provides...more

Smart & Biggar

Health Canada publishes guidance on distinction between advertising and other activities for health products

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Promotional messages and activities regarding a health product are subject to the advertising provisions under the Food and Drugs Act (FDA), the Controlled Drugs and Substances Act and/or their associated regulations. For...more

Smart & Biggar

New Division 11 of the Food and Drug Regulations: Public or Canadian Armed Forces Health Emergencies - Drugs for Immediate Use or...

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Update: Health Canada has prepared an overview of its special access programs, and has finalized the Guidance Document: Sale of Drugs - Public or Canadian Armed Forces Health Emergencies. On February 15, 2023, Regulations...more

Goodwin

FDA Issues Guiding Principles for Good Machine Learning Practice for Medical Device Development

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On October 27, 2021, the U.S. Food and Drug Administration (FDA), Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a set of ten guiding principles meant to aid the...more

McDermott Will & Emery

FDA Issues Good Machine Learning Practice Guiding Principles

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On October 27, 2021, pursuant to the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan (Action Plan), the US Food and Drug Administration (FDA) released its Good Machine Learning...more

Foley Hoag LLP

Public Health Agencies Release “Guiding Principles” for Good Machine Learning Practice

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The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) jointly issued a guidance document entitled, “Good Machine Learning Practice for...more

Smart & Biggar

First year of Project Orbis leads to 38 approvals of cancer therapies, including 8 by Health Canada

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Update: In the Mid-year update: Health products approved in 2021, Health Canada reported the approval of two additional cancer drugs in collaboration with Project Orbis partners between January and June 2021 – Retevmo...more

Smart & Biggar

Federal Court finds reasonable Health Canada’s decision that enantiomer of previously approved drug not entitled to data...

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Update: On July 12, 2021, the Federal Court of Appeal dismissed Janssen’s appeal from Zinn J.’s decision: Janssen Inc v Attorney General of Canada (Minister of Health), 2021 FCA 137 (see article here). On September 18,...more

Smart & Biggar

Health Canada reasonable in finding Natco’s indirect comparison to GENVOYA triggered data protection

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On July 24, 2020, Justice McHaffie of the Federal Court dismissed Natco’s application for judicial review, finding that Health Canada’s refusal to accept Natco’s Abbreviated New Drug Submission (ANDS) for its tenofovir...more

Smart & Biggar

Biosimilars: Comparison chart between Canada, US and Europe

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As more biosimilars continue to be approved across the world, it is helpful to compare the applicable regimes across major jurisdictions. We have collaborated with Brian Coggio of Fish & Richardson, and Mary Foord-Weston and...more

Smart & Biggar

Project Orbis enables concurrent regulatory approval of LENVIMA and KEYTRUDA combination therapy in Canada, U.S. and Australia

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On September 17, 2019, the combination therapy of Eisai’s LENVIMA (lenvatinib) and Merck’s KEYTRUDA (pembrolizumab) for the treatment of advanced endometrial carcinoma received simultaneous approvals by Health Canada, the...more

Bennett Jones LLP

FTC Crackdown on Health Claims for CBD Products and the Canadian Side of the Story

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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

Smart & Biggar

2019 Mid-Year Highlights in Canadian Life Sciences IP

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Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more

Smart & Biggar

Rx IP Update - June 2019

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National Pharmacare Update: Publication of the final report of the Advisory Council - On June 12, 2019, the Minister of Health tabled the final report, A Prescription for Canada: Achieving Pharmacare for All, from the...more

Smart & Biggar

Proposed Amendments to Food and Drug Regulations: Generic drug equivalence, labeling, and related terminology

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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

Smart & Biggar

Final regulations addressing the public release of clinical information now in force

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On March 4, 2019, the final Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information) and Regulations Amending the Medical Devices Regulations (Public Release of Clinical Information)...more

Goodwin

Health Canada Drops Suffix in Biologic and Biosimilar Naming Convention

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Last week, Health Canada announced that biologic drugs, including biosimilars, will be identified “by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix. Both the...more

Smart & Biggar

Enjoy your cannabis hot chocolate, but not so fast on the cannabis beer

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The Canadian Federal government’s proposed amendments to the Cannabis Act and Regulations were published last month. Until February 20, 2019, Health Canada will be accepting comments on the proposed amendments, which set out...more

Goodwin

Tanvex’s New Drug Submission for Filgrastim Biosimilar to Health Canada

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Last October, we reported that Taiwan-based Tanvex BioPharma (“Tanvex”) announced that it had submitted a BLA to the FDA seeking approval of TX-01, a proposed biosimilar referencing Neupogen® (filgrastim) indicated for...more

Smart & Biggar

Rx IP Update - December 2018

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FCA overturns cefaclor damages decision on prejudgment interest issue, provides guidance on NIA defence - On November 23, 2018, the Federal Court of Appeal (FCA) allowed in part Apotex’s appeal of a decision awarding Eli...more

Smart & Biggar

Food businesses face extensive new requirements for food safety in Canada

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In her report on the 2008 Canadian listeriosis outbreak, Independent Investigator Sheila Weatherill highlighted the need for “substantial consolidation and modernization” of the legislative and regulatory framework governing...more

Knobbe Martens

Recall Highlights Medical Device Cybersecurity Issues

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On August 29, the FDA announced a recall of 465,000 implantable pacemakers, citing concerns that hackers may be able to take control of the pacemakers’ settings. This would open patients up to danger from improper pacing or...more

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