News & Analysis as of

Imports Food and Drug Administration (FDA)

Troutman Pepper

FDA Proposes Submission Tracking Number Requirement for ENDS Imports

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In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN)...more

Clark Hill PLC

The Learned Concierge - July 2024, Vol. 10

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The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries....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

McDermott Will & Emery

Imported Drugs: (Possibly) Coming Soon to a State Near You

In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from...more

Holland & Knight LLP

FDA Ramps Up Actions on PFAS

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With the completion of the voluntary phaseout of one form of short-chain per- and polyfluoroalkyl substances (PFAS) as a grease-proofing agent, the U.S. Food and Drug Administration (FDA) has rejected the view that...more

WilmerHale

Federal Circuit Addresses Scope of Medical Device and Drug Infringement Safe Harbor

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On March 25, 2024, the Federal Circuit issued an opinion in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., addressing whether the act of importing two heart valve systems for a medical conference was within the...more

American Conference Institute (ACI)

[Event] 16th Annual Practitioners’ Think Tank on ITC Litigation & Enforcement - May 29th - 30th, Washington, DC

Returning to Washington in May, ACI’s 16th Annual Practitioners’ Think Tank on ITC Litigation & Enforcement is your opportunity to learn from and network with key members of the ITC Bench, senior ITC Attorneys and leading...more

Clark Hill PLC

The Learned Concierge - March 2024, Vol. 6

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The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries....more

K&L Gates LLP

An Overview of the US Food and Drug Administration's Legislative Goals (Part I)

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In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency’s most recent priorities as outlined in FDA’s FY 2024 budget, found here....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

Manatt, Phelps & Phillips, LLP

FDA Approves Florida’s Application to Import Drugs from Canada

On January 5, 2024, the Food and Drug Administration (FDA) authorized the state of Florida’s proposal under the Section 804 Importation Program (SIP) for a period of two years. FDA’s action marks the first time a state drug...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

Akin Gump Strauss Hauer & Feld LLP

FDA Serves Up More Food for Thought: 2024 Will Be a Pivotal Year for the Agency’s Reorganization Efforts

In January, the U.S. Food and Drug Administration (FDA) kicked off the year by announcing a much-anticipated proposal to restructure their human foods program (HFP), and the agency has continued to work on the details of...more

ArentFox Schiff

Cinnamon and Spice but Not Necessarily Nice

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What do eggnog, Christmas pudding, gingerbread cookies, and fruit cake all have in common? Cinnamon. But this year, the spice giving these desserts their holiday cheer could also come with a toxic level of lead....more

Perkins Coie

Food Imports: FDA Proposes Amendments to Prior Notice Rule and Publishes Final Guidance on Prior Notice Compliance

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On November 1, 2023, the U.S. Food and Drug Administration (FDA) published a proposed rule to amend Prior Notice requirements for imported human and animal food in two key ways:  Additionally, on October 13, 2023, FDA...more

Fish & Richardson

Federal Circuit to Consider the Relevance of an Alleged Infringer’s “Intent” in a Hatch-Waxman Safe Harbor Analysis

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The Federal Circuit will consider the relevance of an alleged infringer’s intent in a safe harbor analysis in the appeal of Edwards Lifesciences Corp. v. Meril Life Scis. Pvt.1 The District Court granted summary judgment that...more

Morrison & Foerster LLP

“Line-by-Line” vs. “As-a-Whole” Analysis: Clarifying the Mere Importer and Domestic Industry Analysis

The International Trade Commission’s (“Commission”) majority and dissenting opinions in Certain In Vitro Fertilization Products, Components Thereof, and Products Containing the Same (“In Vitro Fertilization”) illustrate two...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

Epstein Becker & Green

Unpacking Averages: Assessing FDA’s Focus on Enforcing 510(K) Requirements on Imports

A private equity client asked us recently to assess a rumor that FDA was on the warpath in enforcing the 510(k) requirement on medical devices from a particular region. Such a government initiative would significantly deter...more

Akin Gump Strauss Hauer & Feld LLP

FDA User Fee Reauthorization Gains Momentum with Senate HELP Committee Approval

There continues to be no shortage of FDA-related issues in front of Congress this summer. In recent days, the pace of Congressional action on reauthorizing FDA’s user fee programs has significantly picked up with the Senate...more

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