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Canada Food and Drug Administration (FDA)

DLA Piper

Food and Beverage News and Trends - July 2025

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This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. ...more

DLA Piper

Food and Beverage News and Trends - June 2025 #2

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This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. On June 9, HHS Secretary Robert F. Kennedy, Jr., announced that he is “retiring”...more

DLA Piper

Food and Beverage News and Trends - May 2025 #2

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FDA approves three color additives derived from natural sources. In order to “expand the palette of available colors from natural sources for manufacturers to safely use in food,” the FDA announced on May 9 that it has...more

Smart & Biggar

Health Canada publishes Guide to the precision regulating authorities under the Food and Drugs Act

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In March 2025,  Health Canada published a Guide to the precision regulating authorities under the Food and Drugs Act. The Guide sets out the principles, policies, considerations and standards that Health Canada should follow...more

DLA Piper

Food and Beverage News and Trends - March 2025 #2

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This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. Secretary Kennedy takes first steps to eliminate GRAS exception. Health and...more

Nutter McClennen & Fish LLP

Beverage Breakdown (January 2025)

Welcome to Nutter's Beverage Breakdown, a periodic legal update on developments related to the alcohol beverage industry, including industry news, federal and state updates, and more. We look forward to sharing our insights...more

King & Spalding

The Trifecta: What to Expect from a Second Trump Administration and a Republican Congress

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Republicans have swept the 2024 elections, returning Donald Trump to the White House as the 47th President and flipping the Senate to a Republican majority. Having narrowly maintained control of the House of Representatives,...more

Bennett Jones LLP

B.C. Supreme Court Denies Certification of Contested Common Issues in Mentor Breast Implant Litigation

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In Bosco v Mentor Worldwide LLC, 2024 BCSC 1931, the plaintiffs alleged that Mentor's silicone gel-filled breast implants, MemoryGel, caused adverse health effects, including connective tissue disorders (CTDs) and autoimmune...more

ArentFox Schiff

As the (Customs and Trade) World Turns: November 2024

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Welcome to the November 2024 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and...more

Mintz - ML Strategies

2024 Post-Election Analysis

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Following a hotly contested election, Donald Trump is once again the president-elect and will return to the White House on January 20, 2025. He will do so with a dominant electoral college win, potentially a win of the...more

Holland & Knight LLP

A Look at the Upcoming Trump Administration's Policy Priorities

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President-Elect Donald Trump is poised to expand upon policies he implemented during his first term in office, such as those emphasizing limited government, states' rights and lower taxes. Additionally, it is anticipated that...more

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

Knobbe Martens

UK Proposes Approving Medical Devices Based on Approval in Other Countries

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Device manufacturers may soon have access to a new framework for marketing and selling medical devices in the United Kingdom.  On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published...more

Jones Day

Canadian Drug Importation May Undermine Intellectual Property Protection

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The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more

Arnall Golden Gregory LLP

What Lies Ahead, We Have No Way of Knowing: FDA Authorizes Florida’s Drug Importation Program

A recent development with the Food and Drug Administration made us think of a song lyric from Florida native and Rock and Roll Hall of Famer, Tom Petty, “What lies ahead, [we] have no way of knowing.” As a kick-off to 2024,...more

Smart & Biggar

U.S. FDA authorizes Florida plan to import drugs in bulk from Canada

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A proposed program by the state of Florida to import certain prescription drugs from Canada has received the approval of the United States Food and Drug Administration (FDA): FDA news release on January 5, 2024....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

Cooley LLP

FDA Greenlights Florida’s Proposal for Importing Prescription Drugs From Canada

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On Friday, January 5, 2024, the US Food and Drug Administration (FDA) authorized the Section 804 Importation Program (SIP) proposal of Florida’s Agency for Health Care Administration (FAHCA). The SIP is a pathway that allows...more

Foley & Lardner LLP

FDA: Major Policy Shift Authorizes Florida’s Plan to Import Drugs from Canada

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On Friday, January 5, 2024, in a major policy shift, the U.S. Food & Drug Administration (FDA) authorized Florida’s Agency for Health Care Administration’s plan to purchase medicines in bulk for its Medicaid programs,...more

Hogan Lovells

Florida still has a long way to go before it can begin importing certain Canadian drugs

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On January 5, 2024, the U.S. Food and Drug Administration (FDA) authorized Florida’s proposal under the Section 804 Importation Program (SIP) to allow Florida to proceed to the next steps in the regulatory process to import...more

BakerHostetler

FDA Authorizes Florida’s Drug Importation Program

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On Jan. 5, the FDA authorized Florida’s Section 804 Implementation program (SIP), making Florida the first state to secure such approval. Generally, there are three pathways to importing a prescription drug into the United...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

An Interview with Rachel Goode, Ph.D, about Biological Patent Thickets

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Kevin DeJong (Senior Editor) and Shweta Kumar (Editor) from the Big Molecule Watch recently interviewed Rachel Goode, Ph.D. to discuss an article she recently co-authored, “Biological patent thickets and delayed access to...more

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