News & Analysis as of

Imports Federal Food Drug and Cosmetic Act (FFDCA)

Wolf, Greenfield & Sacks, P.C.

Top Five Recent Developments in Section 337 Litigation

2023 was an exciting year for Section 337 litigation at the ITC and 2024 is off to an equally interesting start. In this article, Libbie DiMarco reviews five of the most interesting recent developments in Section 337...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

K&L Gates LLP

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

K&L Gates LLP on

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

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

Quarles & Brady LLP

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

Quarles & Brady LLP on

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

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

BakerHostetler

FDA Authorizes Florida’s Drug Importation Program

BakerHostetler on

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

Fish & Richardson

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

Fish & Richardson on

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

Hogan Lovells

FDA issues final guidance for importing drugs prior to anticipated approval

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) published the final guidance, “Pre-Launch Activities Importation Requests (PLAIR),” describing its policy regarding requests for the importation of unapproved finished...more

Morgan Lewis

FDA Places Mexican-Made Hand Sanitizers on Import Alert Due to Toxin Risks

Morgan Lewis on

The Food and Drug Administration (FDA) issued a press release on January 26 announcing a countrywide import alert on all alcohol-based hand sanitizers manufactured in Mexico due to their potential methanol content. The press...more

Arnall Golden Gregory LLP

A Guide to FDA’s Final Rule on the Importation of Prescription Drugs from Canada

On September 25, 2020, the U.S. Food and Drug Administration issued a final rule entitled, “Importation of Prescription Drugs,” to implement Section 804(b) through (h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)....more

Dechert LLP

U.S. Executive and Legislative Branches Raise the Heat on Slave Labor and Trade Law Violations

Dechert LLP on

Weeks ago, on September 14 2020, the Trump Administration made news by announcing a ban on the importation of certain products made in China’s Xinjiang region, where widespread human rights abuses—including slave labor work...more

Mintz - Health Care Viewpoints

Final Canadian Drug Importation Rule and HHS Certification Issued Under Section 804 of the Food, Drug and Cosmetic Act

As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump...more

Hogan Lovells

FDA postpones foreign inspections amid growing concerns over coronavirus (COVID-19)

Hogan Lovells on

On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020.  This action comes as the latest in a series of agency responses to the coronavirus (COVID-19) outbreaks in foreign...more

Haug Partners LLP

Global Developments and Considerations for Registering Cannabis and Cannabis-Related Trademarks

Haug Partners LLP on

This article discusses the global developments for the registration of cannabis and cannabis-related trademarks in the United States, Canada, Mexico, and the European Union....more

Mintz - Health Care Viewpoints

Administration Finally Releases Proposed Drug Importation Policies for Stakeholder and Public Comments

At the end of July 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump Administration’s two-part...more

Akerman LLP - Health Law Rx

FDA’s Safe Importation Action Plan May Give Florida’s Drug Import Program a Pathway to Approval

At both the federal level and within Florida, there are the beginnings of the seeds of change regarding drug importation policies.  President Trump and Governor DeSantis have both been HUGE supporters of drug importation as a...more

Mintz - Health Care Viewpoints

In Policy Reversal, HHS and FDA Propose Plan to Import Foreign Drugs

On July 31, 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published a proposal, called the Safe Importation Action Plan, to allow certain entities to import...more

King & Spalding

A Gimmick No More? HHS Moves to Authorize Prescription Drug Importation

King & Spalding on

Since its enactment in 2003, Section 804 of the Federal Food, Drug, and Cosmetic Act (FDCA) has been a dead letter in the law. The provision authorizes the importation of certain prescription drugs from Canada, but only if...more

Pillsbury Winthrop Shaw Pittman LLP

Despite Amarin, ITC May Be Right Prescription For Pharma

Foreign-made drugs, nutritional supplements and medical devices imported into the United States with false or misleading labeling or designed to look like an established competing product in violation of the Lanham Act could...more

Jones Day

ITC Institutes Investigation Based on Allegation of Drug Sales Without FDA Approval

Jones Day on

Normally, it is the FDA that monitors the improper distribution of drugs. But, as it turns out, the International Trade Commission (“ITC”) might be able to enter the fray too. On April 18, 2018, the ITC issued a notice...more

Mintz - Health Care Viewpoints

FDA 2017 Year in Review: Therapeutic Products, Part 2

Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space. Part 1 recapped Commissioner Gottlieb’s initiative to tackle drug...more

Hogan Lovells

Hogan Lovells ITC Section 337 Monthly Highlights

Hogan Lovells on

The latest news round-up from our Hogan Lovells ITC Section 337 practice, including a new section featuring "tips from the bench" by former ITC Judge Theodore (Ted) R. Essex. ...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | August 2017 #3

As plant-based beverages appear on more store shelves, the definition of “milk” has become the center of a dispute involving legislatures, regulators, litigators and industry groups. Shook Partners Katie Gates Calderon and...more

Arnall Golden Gregory LLP

You Can Check Out Anytime You Want, But You Can Never Leave: FDA Import Detentions and Recommendations to Minimize Delays

In The Eagles’ song, “Hotel California,” Don Henley sings, “You can check out anytime you want, but you can never leave.” Life science companies can try to import all they want, but that doesn’t mean the products will make it...more

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