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Canada Department of Health and Human Services (HHS)

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

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

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

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

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - September 2022

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Inflation Reduction Act: Stakeholders and commentators continue to review H.R. 5376, the Inflation Reduction Act of 2022 (the Act), which became law on Aug. 16, 2022. Republican leaders on the House Energy & Commerce and...more

ArentFox Schiff

Long COVID – Just the Facts

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The Food and Drug practice at ArentFox Schiff has received numerous inquiries from clients about long COVID, so we decided to ask our in-house scientist, Robert Edwards, Ph.D., Director of Regulatory Science, to prepare an...more

ArentFox Schiff

Drug Importation Lawsuit Stays Alive, For Now

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In July 2020, the Trump Administration issued an Executive Order (the EO) directing the Secretary of the Department of Health and Human Services (HHS) to take certain actions and finalize rulemakings designed to “support the...more

Goodwin

Canada, PhRMA and Others Challenge U.S. Prescription Drug Rules

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As we previously reported, in July 2019 the U.S. Department of Health and Human Services (HHS) announced a Safe Importation Action Plan (Action Plan) created with the FDA to allow the importation of certain prescription drugs...more

King & Spalding

FDA Finalizes Rule and Guidance to Implement Safe Importation Action Plan Aimed at Lowering Prescription Drug Prices

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On September 24, 2020, FDA announced that it was taking action to help lower prescription drug prices by issuing a final rule and a final guidance aimed at facilitating the safe importation of certain prescription drugs....more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – July 2020 #9

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In Washington: Senate Majority Leader Mitch McConnell (R-KY) on Monday told reporters that when the Senate returns next week Republicans will start discussions on the next coronavirus stimulus package with their Democratic...more

King & Spalding

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

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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

Blank Rome LLP

Will HHS’s Safe Importation Action Plan Affect How the Federal Government Purchases Drugs?

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On July 31, the Department of Health and Human Services (“HHS”) and the Food and Drug Administration (“FDA”) announced their latest plan to reduce the prices Americans pay for prescription drugs. The Safe Importation Action...more

Harris Beach Murtha PLLC

With Marijuana Still Illegal in U.S., Personal Use or Involvement in Cannabis Industry Can Affect Entry at Border

As the legal landscape of marijuana use shifts in both the United States and Canada, new questions arise as to the impact of drug use on admission to the United States. Currently, under both U.S. and Canadian federal law,...more

Jones Day

Global Privacy & Cybersecurity Update Issue 18 | June 2018

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JONES DAY CYBERSECURITY, PRIVACY & DATA PROTECTION ATTORNEY SPOTLIGHT: Richard Martinez - Europe's new General Data Protection Regulation ("GDPR") is driving an evolution in corporate privacy practices globally. As...more

Jones Day

Global Privacy & Cybersecurity Update Vol. 16

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UNITED STATES - Regulatory—Policy, Best Practices, and Standards - United States and China Renew Promise Not to Hack - On October 4, U.S. and Chinese officials agreed to not engage in targeted hacking. Per a...more

Jones Day

Senators Urge the Administration to Certify Imports of Prescription Drugs from Canada, Pharmaceutical & Medical Device Update,...

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On May 15, 2017, Sens. Charles Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) sent a letter to the Office of Management and Budget ("OMB") Director Mick Mulvaney prompting him to work with the Department of...more

Dickinson Wright

Healthcare Legal News Volume 5 Number 2

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According to a recent study by Accenture, by 2017 approximately 18 percent of the American public will purchase insurance through exchanges versus relying on traditional employer healthcare coverage or foregoing insurance...more

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